Trial Outcomes & Findings for Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Trial (NCT NCT05189106)
NCT ID: NCT05189106
Last Updated: 2026-06-30
Results Overview
Total levels of baricitinib in the CSF of participants 2 hours after 2 mg and 4 mg oral dosing of baricitinib.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Measured at baseline, 8 weeks from baseline, and 16 weeks from baseline. Results reported at the completion of the study.
Results posted on
2026-06-30
Participant Flow
Pre-assignment details include completing a screening visit over a period of 30 days. If the results from the screening visit determine that a participant is eligible, then the participant is assignment to the treatment arm. Once assigned to the treatment arm, all participants will receive 2 mg baricitinib by mouth daily for the first 8 weeks then 4 mg baricitinib by mouth daily for the remaining 16 weeks for a total treatment period of 24 weeks.
Participant milestones
| Measure |
Participants With Alzheimer's Disease (AD)
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs. All participants will receive 2 mg baricitinib by mouth daily for the first 8 weeks then 4 mg baricitinib by mouth daily for the remaining 16 weeks for a total treatment period of 24 weeks.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants will receive 2 mg baricitinib by mouth daily for the first 8 weeks then 4 mg baricitinib by mouth daily for the remaining 16 weeks for a total treatment period of 24 weeks.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs. All participants will receive 2 mg baricitinib by mouth daily for the first 8 weeks then 4 mg baricitinib by mouth daily for the remaining 16 weeks for a total treatment period of 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
1
|
|
Overall Study
COMPLETED
|
6
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One AD participant was missing genotype information.
Baseline characteristics by cohort
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 Participants
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=9 Participants
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 Participants
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.4 Years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
58.2 Years
STANDARD_DEVIATION 14.2 • n=9 Participants
|
48.7 Years
STANDARD_DEVIATION 0 • n=1 Participants
|
62.3 Years
STANDARD_DEVIATION 12.8 • n=17 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=7 Participants
|
7 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
9 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=7 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=1 Participants
|
8 Participants
n=17 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=7 Participants
|
9 Participants
n=9 Participants
|
1 Participants
n=1 Participants
|
17 Participants
n=17 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=17 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=7 Participants
|
9 Participants
n=9 Participants
|
1 Participants
n=1 Participants
|
17 Participants
n=17 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=17 Participants
|
|
C9orf72 Repeat Expansion
Positive C9orf72 Repeat Expansion
|
0 Participants
n=7 Participants • One AD participant was missing genotype information.
|
1 Participants
n=9 Participants • One AD participant was missing genotype information.
|
1 Participants
n=1 Participants • One AD participant was missing genotype information.
|
2 Participants
n=17 Participants • One AD participant was missing genotype information.
|
|
MoCA Total Score
|
17.7 MoCA Total Score
STANDARD_DEVIATION 5.6 • n=7 Participants • The MoCA assessment was only completed for participants in the AD group.
|
—
|
—
|
17.7 MoCA Total Score
STANDARD_DEVIATION 5.6 • n=7 Participants • The MoCA assessment was only completed for participants in the AD group.
|
|
ALSFRS-R Total Score
|
—
|
35.0 ALSFRS-R Total Score
STANDARD_DEVIATION 5.4 • n=9 Participants • The ALSFRS-R assessment was only completed for participants in the ALS and AGC groups.
|
48.0 ALSFRS-R Total Score
STANDARD_DEVIATION 0 • n=1 Participants • The ALSFRS-R assessment was only completed for participants in the ALS and AGC groups.
|
36.3 ALSFRS-R Total Score
STANDARD_DEVIATION 6.5 • n=10 Participants • The ALSFRS-R assessment was only completed for participants in the ALS and AGC groups.
|
|
APOE Genotype
E2/E3
|
0 Participants
n=7 Participants • One AD participant was missing genotype information.
|
1 Participants
n=9 Participants • One AD participant was missing genotype information.
|
0 Participants
n=1 Participants • One AD participant was missing genotype information.
|
1 Participants
n=17 Participants • One AD participant was missing genotype information.
|
|
APOE Genotype
E3/E3
|
1 Participants
n=7 Participants • One AD participant was missing genotype information.
|
7 Participants
n=9 Participants • One AD participant was missing genotype information.
|
0 Participants
n=1 Participants • One AD participant was missing genotype information.
|
8 Participants
n=17 Participants • One AD participant was missing genotype information.
|
|
APOE Genotype
E3/E4
|
5 Participants
n=7 Participants • One AD participant was missing genotype information.
|
1 Participants
n=9 Participants • One AD participant was missing genotype information.
|
0 Participants
n=1 Participants • One AD participant was missing genotype information.
|
6 Participants
n=17 Participants • One AD participant was missing genotype information.
|
|
APOE Genotype
E4/E4
|
0 Participants
n=7 Participants • One AD participant was missing genotype information.
|
0 Participants
n=9 Participants • One AD participant was missing genotype information.
|
1 Participants
n=1 Participants • One AD participant was missing genotype information.
|
1 Participants
n=17 Participants • One AD participant was missing genotype information.
|
|
C9orf72 Repeat Expansion
Negative C9orf72 Repeat Expansion
|
6 Participants
n=7 Participants • One AD participant was missing genotype information.
|
8 Participants
n=9 Participants • One AD participant was missing genotype information.
|
0 Participants
n=1 Participants • One AD participant was missing genotype information.
|
14 Participants
n=17 Participants • One AD participant was missing genotype information.
|
|
Months since symptom onset
|
48.4 Months
STANDARD_DEVIATION 29.9 • n=7 Participants • The participant in the AGC group is not included in the results of this baseline measure.
|
28 Months
STANDARD_DEVIATION 16.9 • n=9 Participants • The participant in the AGC group is not included in the results of this baseline measure.
|
—
|
36.9 Months
STANDARD_DEVIATION 24.9 • n=16 Participants • The participant in the AGC group is not included in the results of this baseline measure.
|
|
Months since diagnosis
|
30 Months
STANDARD_DEVIATION 16.6 • n=7 Participants • The participant in the AGC group is not included in the results of this baseline measure.
|
17.7 Months
STANDARD_DEVIATION 15.1 • n=9 Participants • The participant in the AGC group is not included in the results of this baseline measure.
|
—
|
23.1 Months
STANDARD_DEVIATION 16.5 • n=16 Participants • The participant in the AGC group is not included in the results of this baseline measure.
|
PRIMARY outcome
Timeframe: Measured at baseline, 8 weeks from baseline, and 16 weeks from baseline. Results reported at the completion of the study.Population: One ALS Participant was not included because the participant early terminated prior to the Week 8 visit.
Total levels of baricitinib in the CSF of participants 2 hours after 2 mg and 4 mg oral dosing of baricitinib.
Outcome measures
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 Participants
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=8 Participants
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 Participants
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
|---|---|---|---|
|
CSF Concentration of Baricitinib
Week 8
|
1.244 nmol/L
Standard Error 0.301
|
1.748 nmol/L
Standard Error 0.282
|
0.460 nmol/L
Standard Error 0.797
|
|
CSF Concentration of Baricitinib
Week 16
|
2.469 nmol/L
Standard Error 0.464
|
3.804 nmol/L
Standard Error 0.489
|
1.965 nmol/L
Standard Error 1.228
|
PRIMARY outcome
Timeframe: Measured at baseline, 8 weeks from baseline, and 16 weeks from baseline. Results reported at the completion of the study.The inflammatory biomarker CCL2 quantified in the CSF of participants after 2 mg of 4 mg oral dose relative to baseline.
Outcome measures
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 Participants
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=9 Participants
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 Participants
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
|---|---|---|---|
|
CSF CCL2 Concentration
Week 16
|
408.264 pg/mL
Interval 345.43 to 482.52
|
442.804 pg/mL
Interval 373.25 to 525.32
|
483.589 pg/mL
Interval 310.78 to 752.48
|
|
CSF CCL2 Concentration
Week 08
|
407.202 pg/mL
Interval 335.26 to 494.58
|
473.487 pg/mL
Interval 397.9 to 563.43
|
503.127 pg/mL
Interval 300.81 to 841.5
|
|
CSF CCL2 Concentration
Week 00
|
417.640 pg/mL
Interval 349.85 to 498.56
|
465.868 pg/mL
Interval 398.5 to 544.62
|
501.728 pg/mL
Interval 314.03 to 801.61
|
SECONDARY outcome
Timeframe: Measured at baseline, 8 weeks from baseline, and 16 weeks from baseline. Results reported at the completion of the study.The inflammatory biomarker CXCL10 protein quantified in the CSF of participants after 2 mg of 4 mg oral dose relative to baseline.
Outcome measures
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 Participants
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=9 Participants
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 Participants
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
|---|---|---|---|
|
CSF C-X-C Motif Chemokine Ligand 10 (CXCL10) Concentration
Week 00
|
610.760 pg/mL
Interval 446.3 to 835.83
|
635.928 pg/mL
Interval 482.22 to 838.62
|
325.587 pg/mL
Interval 141.97 to 746.7
|
|
CSF C-X-C Motif Chemokine Ligand 10 (CXCL10) Concentration
Week 08
|
479.915 pg/mL
Interval 348.76 to 660.4
|
435.797 pg/mL
Interval 324.68 to 584.95
|
302.689 pg/mL
Interval 130.07 to 704.39
|
|
CSF C-X-C Motif Chemokine Ligand 10 (CXCL10) Concentration
Week 16
|
428.966 pg/mL
Interval 305.16 to 603.01
|
393.507 pg/mL
Interval 284.54 to 544.2
|
242.252 pg/mL
Interval 98.392 to 596.46
|
SECONDARY outcome
Timeframe: Measured at baseline, 8 weeks from baseline, and 16 weeks from baseline. Results reported at the completion of the study.The inflammatory biomarker IL-6 protein quantified in the CSF of participants after 2 mg of 4 mg oral dose relative to baseline.
Outcome measures
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 Participants
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=9 Participants
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 Participants
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
|---|---|---|---|
|
CSF Interleukin-6 (IL-6) Concentration
Week 00
|
1.148 pg/mL
Interval 0.929 to 1.419
|
1.296 pg/mL
Interval 1.075 to 1.562
|
1.012 pg/mL
Interval 0.578 to 1.771
|
|
CSF Interleukin-6 (IL-6) Concentration
Week 08
|
0.985 pg/mL
Interval 0.71 to 1.366
|
1.515 pg/mL
Interval 1.118 to 2.053
|
1.086 pg/mL
Interval 0.457 to 2.581
|
|
CSF Interleukin-6 (IL-6) Concentration
Week 16
|
1.058 pg/mL
Interval 0.723 to 1.548
|
1.195 pg/mL
Interval 0.8 to 1.786
|
0.988 pg/mL
Interval 0.361 to 2.703
|
SECONDARY outcome
Timeframe: Measured at baseline, 8 weeks from baseline, and 16 weeks from baseline. Results reported at the completion of the study.The neuronal death biomarker NfL protein quantified in the CSF of participants after 2 mg of 4 mg oral dose relative to baseline.
Outcome measures
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 Participants
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=9 Participants
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 Participants
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
|---|---|---|---|
|
CSF Neurofilament Light Chain (NfL) Concentration
Week 00
|
2061.076 pg/mL
Interval 1358.6 to 3126.7
|
5523.361 pg/mL
Interval 3824.6 to 7976.7
|
892.150 pg/mL
Interval 296.2 to 2687.1
|
|
CSF Neurofilament Light Chain (NfL) Concentration
Week 08
|
2228.815 pg/mL
Interval 1439.5 to 3451.0
|
5795.631 pg/mL
Interval 3938.8 to 8527.7
|
810.630 pg/mL
Interval 254.96 to 2577.3
|
|
CSF Neurofilament Light Chain (NfL) Concentration
Week 16
|
2296.714 pg/mL
Interval 1481.7 to 3560.0
|
5504.183 pg/mL
Interval 3728.7 to 8125.0
|
944.850 pg/mL
Interval 296.33 to 3012.7
|
SECONDARY outcome
Timeframe: Measured at screening, baseline (Week 00), 8 weeks from baseline, and 16 weeks from baseline. Results reported at the completion of the study.The neuronal death biomarker Tau protein quantified in the CSF of participants after 2 mg of 4 mg oral dose relative to baseline.
Outcome measures
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 Participants
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=9 Participants
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 Participants
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
|---|---|---|---|
|
CSF Tau Concentration
Screening
|
839.368 pg/mL
Interval 563.1 to 1251.2
|
293.213 pg/mL
Interval 206.2 to 416.94
|
557.798 pg/mL
Interval 194.0 to 1603.8
|
|
CSF Tau Concentration
Week 00
|
853.798 pg/mL
Interval 581.48 to 1253.7
|
275.299 pg/mL
Interval 196.19 to 386.3
|
553.701 pg/mL
Interval 200.4 to 1529.8
|
|
CSF Tau Concentration
Week 08
|
876.145 pg/mL
Interval 437.45 to 1754.8
|
209.769 pg/mL
Interval 111.94 to 393.11
|
502.068 pg/mL
Interval 79.924 to 3153.9
|
|
CSF Tau Concentration
Week 16
|
929.816 pg/mL
Interval 592.45 to 1459.3
|
273.589 pg/mL
Interval 183.44 to 408.04
|
496.010 pg/mL
Interval 150.52 to 1634.5
|
SECONDARY outcome
Timeframe: Measured at baseline, 8 weeks from baseline, and 16 weeks from baseline. Results reported at the completion of the study.The neuronal death biomarker pTau protein quantified in the CSF of participants after 2 mg of 4 mg oral dose relative to baseline.
Outcome measures
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 Participants
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=9 Participants
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 Participants
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
|---|---|---|---|
|
CSF Phospho-tau (pTau)
Week 00
|
90.618 pg/mL
Interval 46.863 to 175.22
|
13.361 pg/mL
Interval 7.469 to 23.901
|
28.220 pg/mL
Interval 4.93 to 161.53
|
|
CSF Phospho-tau (pTau)
Week 08
|
94.402 pg/mL
Interval 44.313 to 201.11
|
12.860 pg/mL
Interval 6.596 to 25.071
|
26.560 pg/mL
Interval 3.591 to 196.44
|
|
CSF Phospho-tau (pTau)
Week 16
|
97.125 pg/mL
Interval 45.491 to 207.37
|
12.095 pg/mL
Interval 6.169 to 23.712
|
22.690 pg/mL
Interval 3.05 to 168.8
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 year.Investigators will quantify the occurrence of treatment-emergent adverse events, treatment-emergent serious adverse events, and treatment-emergent clinically significant abnormalities in clinical and laboratory values both overall and among AD and ALS participants separately. AEs will be coded to system organ class and preferred terms from a consistent version of the MedDRA library and summarized as counts of events and proportions of participants experiencing a given type of event. The distribution of severity, relationship to the study intervention, action taken with respect to study intervention, and outcome of all treatment emergent adverse effects will be tabulated. The rate of adverse effects in trial participants will be compared to the frequency of adverse effects documented in the package insert.
Outcome measures
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 Participants
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=9 Participants
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 Participants
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
|---|---|---|---|
|
Relatedness of Total Number of Adverse Events Across All Participants
Not Related to Study Treatment
|
4 Number of Events
|
80 Number of Events
|
7 Number of Events
|
|
Relatedness of Total Number of Adverse Events Across All Participants
Unlikely Related to Study Treatment
|
5 Number of Events
|
11 Number of Events
|
0 Number of Events
|
|
Relatedness of Total Number of Adverse Events Across All Participants
Possibly Related to Study Treatment
|
5 Number of Events
|
2 Number of Events
|
0 Number of Events
|
|
Relatedness of Total Number of Adverse Events Across All Participants
Probably Related to Study Treatment
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Relatedness of Total Number of Adverse Events Across All Participants
Definitely Related to Study Treatment
|
0 Number of Events
|
0 Number of Events
|
0 Number of Events
|
Adverse Events
Participants With Alzheimer's Disease (AD)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Participants With Amyotrophic Lateral Sclerosis (ALS)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 participants at risk
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=9 participants at risk
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 participants at risk
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
|---|---|---|---|
|
Immune System Disorders
Hypersensitivity
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Respiratory, Thoracic and Mediastinal Disorders
Pulmonary embolism
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
Other adverse events
| Measure |
Participants With Alzheimer's Disease (AD)
n=7 participants at risk
This study included a group of participants who have subjective cognitive decline, mild neurocognitive disorder, or major neurocognitive disorder, either possible or probable AD. Eligible participants must be between 55 and 90 years old, inclusive, and have a MoCA score that is greater than or equal to 8 at screening. Participants or a surrogate representative must provide written informed consent prior to screening. A study partner must be willing to accompany the participant to visits and complete partner study forms. All participants must be able and willing to undergo LPs.
|
Participants With Amyotrophic Lateral Sclerosis (ALS)
n=9 participants at risk
This study includes a group of participants who who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.
|
Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene
n=1 participants at risk
This study includes a group of participants that are Asymptomatic individuals with an ALS-causative gene per CLIA-certified genetic testing results are also eligible to participate in this study at MGH. Participants must provide written informed consent prior to screening. Eligible participants must be between 18 and 80 years old, inclusive, have an ALSFRS-R score greater than or equal to 27, and be ambulatory at screening. Participants not taking or on a stable dose of any FDA approved treatment for ALS for at least 30 days or 1 cycle and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements. All participants must be able and willing to undergo LPs.
|
|---|---|---|---|
|
Blood and Lymphatic System Disorders
Leukocytosis
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Cardiac Disorders
Atrial fibrillation
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/9 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Ear and Labyrinth Disorders
Tinnitus
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/9 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
100.0%
1/1 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Ear and Labyrinth Disorders
Vertigo
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Gastrointestinal Disorders
Abdominal discomfort
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Gastrointestinal Disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Gastrointestinal Disorders
Constipation
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
22.2%
2/9 • Number of events 2 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Gastrointestinal Disorders
Diarrhoea
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Gastrointestinal Disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/9 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Gastrointestinal Disorders
Nausea
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
100.0%
1/1 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Gastrointestinal Disorders
Oral blood blister
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/9 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Gastrointestinal Disorders
Toothache
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Gastrointestinal Disorders
Vomiting
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/9 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
100.0%
1/1 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
General Disorders
Chest pain
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
General Disorders
Fatigue
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
General Disorders
Feeling cold
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
General Disorders
Medical device site pain
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
General Disorders
Oedema peripheral
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
22.2%
2/9 • Number of events 3 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
100.0%
1/1 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
General Disorders
Peripheral swelling
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
General Disorders
Pyrexia
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
General Disorders
Swelling
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
22.2%
2/9 • Number of events 2 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Infections and Infestations
Bronchitis
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Infections and Infestations
COVID-19
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/9 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Infections and Infestations
Upper respiratory tract infection
|
28.6%
2/7 • Number of events 2 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Infections and Infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/9 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Injury, Poisoning and Procedural Complications
Contusion
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
22.2%
2/9 • Number of events 2 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
100.0%
1/1 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Injury, Poisoning and Procedural Complications
Fall
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
55.6%
5/9 • Number of events 10 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Injury, Poisoning and Procedural Complications
Post lumbar puncture syndrome
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
55.6%
5/9 • Number of events 6 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
100.0%
1/1 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Injury, Poisoning and Procedural Complications
Procedural dizziness
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Injury, Poisoning and Procedural Complications
Procedural nausea
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Injury, Poisoning and Procedural Complications
Procedural pain
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
88.9%
8/9 • Number of events 13 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
100.0%
1/1 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Investigations
Carbon dioxide increased
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Investigations
Computerised tomogram thorax
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Investigations
Human metapneumovirus test positive
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Metabolism and Nutrition Disorders
Decreased appetite
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Musculoskeletal and Connective Tissue Disorders
Arthralgia
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Musculoskeletal and Connective Tissue Disorders
Back pain
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Musculoskeletal and Connective Tissue Disorders
Flank pain
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Musculoskeletal and Connective Tissue Disorders
Muscular weakness
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Musculoskeletal and Connective Tissue Disorders
Myalgia
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Musculoskeletal and Connective Tissue Disorders
Pain in extremity
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Nervous System Disorders
Balance disorder
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
22.2%
2/9 • Number of events 2 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Nervous System Disorders
Cerebral haematoma
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Nervous System Disorders
Dizziness
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Nervous System Disorders
Headache
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
66.7%
6/9 • Number of events 7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Nervous System Disorders
Hypoaesthesia
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Psychiatric Disorders
Agitation
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/9 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Psychiatric Disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/9 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Respiratory, Thoracic and Mediastinal Disorders
Bronchial secretion retention
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Respiratory, Thoracic and Mediastinal Disorders
Cough
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Respiratory, Thoracic and Mediastinal Disorders
Dyspnoea
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Skin and Subcutaneous Tissue Disorders
Pain of skin
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Skin and Subcutaneous Tissue Disorders
Skin discolouration
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Vascular Disorders
Deep vein thrombosis
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Vascular Disorders
Haematoma
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Vascular Disorders
Hypertension
|
14.3%
1/7 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/9 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
|
Vascular Disorders
Hypotension
|
0.00%
0/7 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
11.1%
1/9 • Number of events 1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
0.00%
0/1 • From enrollment through study completion, an average of 1 year.
Adverse events are separated by the three different participant diagnostic groups: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), and Asymptomatic Gener Carrier (AGC) for ALS. AEs are not separated by dosage because all participants who completed the study received no drug for 8 weeks, followed by 2 mg per day of baricitinib for the first 8 weeks and then 4 mg per day of baricitinib for 16 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place