Trial Outcomes & Findings for Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients (NCT NCT04388254)
NCT ID: NCT04388254
Last Updated: 2025-04-22
Results Overview
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11-item: Change from baseline in cognition over the course of 24 months Possible range in score: 0-70; Subscales are summed; Higher values represent a more cognitively impaired participant Decrease in mean value represents improvement in cognition from one timepoint to the next.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
220 participants
Primary outcome timeframe
Day 1 to Month 24
Results posted on
2025-04-22
Participant Flow
Participant milestones
| Measure |
Simufilam 100 mg Oral Tablets w/ Mild Alzheimer's Disease
Simufilam 100 mg oral tablets administered twice daily (BID); Subjects with a Mini Mental State Examination (MMSE) score of \>=21 are included in Mild group
|
Simufilam 100 mg Oral Tablets/Placebo/Simufilam 100 mg Oral Tablets w/ Mild Alzheimer's Disease
Subjects with a Mini Mental State Examination (MMSE) score of \>=21 are included in Mild group;
The placebo arm is only from Month 12 to Month 18. Day 1 to Month 12, as well as Month 18 to Month 24 are open-label treatment periods of simufilam 100 mg b.i.d.
Simufilam 100 mg oral tablet: Simufilam 100 mg oral tablet for b.i.d. administration;
Placebo: Matching placebo oral tablets
|
Simufilam 100 mg Oral Tablets w/ Moderate Alzheimer's Disease
Simufilam 100 mg oral tablets administered twice daily (BID); Subjects with a Mini Mental State Examination (MMSE) score of \<=20 are included in Moderate group
|
Simufilam 100 mg Oral Tablets/Placebo/Simufilam 100 mg Oral Tablets w/ Moderate Alzheimer's Disease
Subjects with a Mini Mental State Examination (MMSE) score of \<=20 are included in Moderate group;
The placebo arm is only from Month 12 to Month 18. Day 1 to Month 12, as well as Month 18 to Month 24 are open-label treatment periods of simufilam 100 mg b.i.d.
Simufilam 100 mg oral tablet: Simufilam 100 mg oral tablet for b.i.d. administration
Placebo: Matching placebo oral tablets
|
|---|---|---|---|---|
|
Open Label Period 1 (Mth 1 to Mth 12)
STARTED
|
134
|
0
|
85
|
0
|
|
Open Label Period 1 (Mth 1 to Mth 12)
Completed 12 Months and Chose Not to Continue
|
15
|
0
|
5
|
0
|
|
Open Label Period 1 (Mth 1 to Mth 12)
Discontinued Before Completing 12 Months
|
30
|
0
|
13
|
0
|
|
Open Label Period 1 (Mth 1 to Mth 12)
Completed 12 Months and Chose to Continue
|
104
|
0
|
72
|
0
|
|
Open Label Period 1 (Mth 1 to Mth 12)
COMPLETED
|
104
|
0
|
72
|
0
|
|
Open Label Period 1 (Mth 1 to Mth 12)
NOT COMPLETED
|
30
|
0
|
13
|
0
|
|
Double Blind Treatment (Mth12 to Mth18)
STARTED
|
48
|
41
|
32
|
35
|
|
Double Blind Treatment (Mth12 to Mth18)
Discontinued During Double Blind Treatment Period
|
5
|
7
|
6
|
6
|
|
Double Blind Treatment (Mth12 to Mth18)
COMPLETED
|
43
|
34
|
26
|
29
|
|
Double Blind Treatment (Mth12 to Mth18)
NOT COMPLETED
|
5
|
7
|
6
|
6
|
|
Open Label Period 3 (Mth 18 to Mth 24)
STARTED
|
43
|
34
|
26
|
29
|
|
Open Label Period 3 (Mth 18 to Mth 24)
Discontinued During Period 3
|
4
|
0
|
4
|
3
|
|
Open Label Period 3 (Mth 18 to Mth 24)
COMPLETED
|
39
|
34
|
22
|
26
|
|
Open Label Period 3 (Mth 18 to Mth 24)
NOT COMPLETED
|
4
|
0
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One moderate subject had their baseline MMSE collected after day 1 dose administration.
Baseline characteristics by cohort
| Measure |
Moderate Alzheimer's Disease
n=85 Participants
Subjects with a Mini Mental State Examination (MMSE) score of \<=20 are included in Moderate group
|
Mild Alzheimer's Disease
n=134 Participants
Subjects with a Mini Mental State Examination (MMSE) score of \>=21 are included in Mild group
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
0 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
0 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
26 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
48 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Age, Categorical
>=65 years
|
63 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
108 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
171 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 8.7 • n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
70.8 years
STANDARD_DEVIATION 7.93 • n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
70.7 years
STANDARD_DEVIATION 8.21 • n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
68 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
123 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
66 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
96 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
39 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
48 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
95 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
171 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
0 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
0 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
0 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
0 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
0 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
6 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
0 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
1 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
4 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
6 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Race (NIH/OMB)
White
|
76 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
129 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
205 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
0 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
0 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
1 Participants
n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
1 Participants
n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
|
Body Mass Index (kg/m^2)
|
25.52 kg/m2
STANDARD_DEVIATION 4.046 • n=99 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
28.44 kg/m2
STANDARD_DEVIATION 5.740 • n=107 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
27.33 kg/m2
STANDARD_DEVIATION 5.333 • n=206 Participants • One moderate subject had their baseline MMSE collected after day 1 dose administration.
|
PRIMARY outcome
Timeframe: Day 1 to Month 24Population: Full Analysis set; Overall number of participants is the number for each arm that completed a ADAS-Cog-11 assessment at baseline and month 24.
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11-item: Change from baseline in cognition over the course of 24 months Possible range in score: 0-70; Subscales are summed; Higher values represent a more cognitively impaired participant Decrease in mean value represents improvement in cognition from one timepoint to the next.
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=20 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
n=39 Participants
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
n=24 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
n=33 Participants
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Change From Baseline in ADAS-Cog-11
|
11.05 Change in scale units
Standard Error 1.19
|
0.07 Change in scale units
Standard Error 1.15
|
14.26 Change in scale units
Standard Error 1.79
|
1.04 Change in scale units
Standard Error 1.65
|
PRIMARY outcome
Timeframe: Month 12 to Month 24Population: Full Analysis set; Overall number of participants is the number for each arm/group that completed a ADAS-Cog-11 assessment at month 12 and month 24.
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11-item: Change from baseline in cognition Starting at month 12 through month 24; Possible range in score: 0-70; Higher values represent a more cognitively impaired participant; Decrease in mean value represents improvement in cognition from one timepoint to the next.
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=19 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
n=35 Participants
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
n=23 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
n=30 Participants
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Change From Baseline in ADAS-Cog-11 (Month 12 to Month 24)
|
7.39 Change in scale units
Standard Error 1.447
|
1.93 Change in scale units
Standard Error 1.128
|
6.97 Change in scale units
Standard Error 1.404
|
2.45 Change in scale units
Standard Error 1.225
|
PRIMARY outcome
Timeframe: Day 1 to Month 12 and month 18 to month 24The most frequently reported Treatment Emergent Adverse Events indicative of abnormal vital signs (hypertension/worsening of hypertension and blood pressure increase) of simufilam (PTI-125) during the open label portion of the study: Open-label period 1 (Day 1 to Month 12) and open-label period 2 (Month 18 to Month 24)
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=171 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Safety and Tolerability (Open Label Abnormal Vital Signs)
Blood pressure increase
|
6 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Abnormal Vital Signs)
The number of subjects that did not report hypertension or did not have worsening of hypertension
|
152 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Abnormal Vital Signs)
Hypertension/worsening hypertension
|
13 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12 to month 18The most frequently reported Treatment Emergent Adverse Event indicative of abnormal vital signs (hypotension) of simufilam (PTI-125) or placebo during the randomized withdraw portion of the study : Month 12 to Month 18
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=45 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
n=37 Participants
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Safety and Tolerability (Randomize Withdraw Abnormal Vital Signs)
Number of subjects that reported hypotension
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Safety and Tolerability (Randomize Withdraw Abnormal Vital Signs)
Number of subjects that did not report hypotension
|
43 Participants
|
37 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Month 12 and month 18 to month 24The number of subjects that had Treatment Emergent Adverse Events indicative of abnormal Electrocardiogram results while on simufilam (PTI-125) during the open label portion of the study: Open-label period 1 (Day 1 to Month 12) and open-label period 2 (Month 18 to Month 24)
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=171 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Coronary artery disease
|
2 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Mitral valve incompetence
|
2 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Subjects that reported TEAEs that were not related to Electrocardiogram results
|
150 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Acute left ventricular failure
|
1 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Acute myocardial infarction
|
3 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Angina pectoris
|
2 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Aortic valve incompetence
|
1 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Atrial fibrillation
|
4 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Atrial tachycardia
|
1 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Bradycardia
|
3 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Cardiogenic shock
|
1 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Electrocardiogram Results)
Sinus tachycardia
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12 to Month 18The number of subjects that had Treatment Emergent Adverse Events indicative of abnormal Electrocardiogram results while on simufilam (PTI-125) or placebo during the randomized withdraw portion of the study: Month 12 to Month 18
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=45 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
n=37 Participants
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Safety and Tolerability (Randomize Withdraw Electrocardiogram Results)
Acute Myocardial Infarction
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Safety and Tolerability (Randomize Withdraw Electrocardiogram Results)
Arrhymia
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability (Randomize Withdraw Electrocardiogram Results)
Atrial Fibrillation
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability (Randomize Withdraw Electrocardiogram Results)
Atrioventricular block first degree
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability (Randomize Withdraw Electrocardiogram Results)
Cardiomegaly
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability (Randomize Withdraw Electrocardiogram Results)
Subjects that had TEAEs that were not related Electrocadiogram results
|
43 Participants
|
33 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Month 12 and month 18 to month 24The most frequently reported Treatment Emergent Adverse Events indicative of abnormal physical examination (weight increase or weight decrease) while administered simufilam (PTI-125) during the open label portion of the study: Open-label period 1 (Day 1 to Month 12) and open-label period 2 (Month 18 to Month 24)
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=171 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Safety and Tolerability (Open Label Abnormal Physical Examination)
Weight decrease
|
4 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Abnormal Physical Examination)
Weight increase
|
2 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Abnormal Physical Examination)
Number of subjects that reported TEAEs not indicative of weight change
|
165 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12 to Month 18The number of subjects that had Treatment Emergent Adverse Events of indicative of abnormal physical examination while on simufilam (PTI-125) or placebo during the randomized withdraw portion of the study: Month 12 to Month 18
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=45 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
n=37 Participants
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Safety and Tolerability (Randomize Withdraw Abnormal Physical Examination Findings)
Subjects that did not report TEAEs of abnormal weight decrease
|
45 Participants
|
35 Participants
|
—
|
—
|
|
Safety and Tolerability (Randomize Withdraw Abnormal Physical Examination Findings)
Weight decrease
|
0 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Month 12 and month 18 to month 24Treatment Emergent Adverse Events when three or more subjects reported abnormal clinical laboratory results while on simufilam (PTI-125) during the open label portion of the study: Open-label period 1 (Day 1 to Month 12) and open-label period 2 (Month 18 to Month 24)
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=171 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Safety and Tolerability (Open Label Abnormal Clinical Laboratory Results)
Hyperlipidaemia
|
3 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Abnormal Clinical Laboratory Results)
Hypophosphataemia
|
3 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Abnormal Clinical Laboratory Results)
Subjects that reported 2 or less TEAEs indicative of clinical laboratory results
|
162 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability (Open Label Abnormal Clinical Laboratory Results)
Hyperkalaemia
|
3 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12 to Month 18Treatment Emergent Adverse Events when two or more subjects reported abnormal clinical laboratory results while on simufilam (PTI-125) or placebo during the randomized withdraw portion of the study: Month 12 to Month 18
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=45 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
n=37 Participants
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Safety and Tolerability (Randomize Withdraw Abnormal Clinical Laboratory Results)
Leukocytosis
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Safety and Tolerability (Randomize Withdraw Abnormal Clinical Laboratory Results)
Haematuria
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability (Randomize Withdraw Abnormal Clinical Laboratory Results)
Two subjects or less that report TEAEs of abnormal clinical laboratory results or none at all.
|
43 Participants
|
34 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Month 12Change from baseline to month 12 in Cerebral Spinal Fluid for Triggering Receptor Expressed on Myeloid Cells 2 (TREM2) Mean Concentration (pg/mL) (samples stored at -70 degrees Celsius; assays performed at Abilene Christian University Bioanalytics Laboratory)
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=13 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Cerebral Spinal Fluid for Triggering Receptor Expressed on Myeloid Cells 2 (TREM2) Mean Concentration (pg/mL)
|
-4093.31 pg/mL
Standard Deviation 4730.736
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Month 12Change from baseline to month 12 in Cerebral Spinal Fluid for Tau Protein Mean Concentration (pg/mL) (samples stored at -70 degrees Celsius; assays performed at Abilene Christian University Bioanalytics Laboratory)
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=18 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Cerebral Spinal Fluid for Tau Protein Mean Concentration (pg/mL)
|
-12.26 pg/mL
Standard Deviation 96.238
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Month 12Change from baseline to month 12 in Cerebral Spinal Fluid for Neurogranin Mean Concentration (pg/mL) (samples stored at -70 degrees Celsius; assays performed at Abilene Christian University Bioanalytics Laboratory)
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=18 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Cerebral Spinal Fluid for Neurogranin Mean Concentration (pg/mL)
|
-115.15 pg/mL
Standard Deviation 237.256
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Month 12Change from baseline to month 12 in Cerebral Spinal Fluid for Neurofilament Light Chain Protein Mean Concentration (pg/mL) (samples stored at -70 degrees Celsius; assays performed at Abilene Christian University Bioanalytics Laboratory)
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=18 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Cerebral Spinal Fluid for Neurofilament Light Chain Protein Mean Concentration (pg/mL)
|
-10.00 pg/mL
Standard Deviation 95.504
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Month 12Change from baseline to month 12 in Cerebral Spinal Fluid for Glial Fibrillary Acidic Protein Mean Concentration (pg/mL) (samples stored at -70 degrees Celsius; assays performed at Abilene Christian University Bioanalytics Laboratory)
Outcome measures
| Measure |
Moderate Alzheimer's Disease, 24 Months of Simufilam
n=18 Participants
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Mild Alzheimer's Disease, 24 Months of Simufilam
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects were administered Simufilam over the course of the whole trial (from day 1 to month 24)
|
Moderate Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Moderate subjects: Mini Mental State Examination (MMSE) score of \<=20
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
Mild Alzheimer's Disease, Interrupted Simufilam Placebo Administration From Month 12 to Month 18
* Mild Subjects with a Mini Mental State Examination (MMSE) score of \>=21
* Subjects that were administered Simufilam from day 1 to month 12 and month 18 to 24 with 6 month simufilam interruption (placebo administration from month 12 to month 18)
|
|---|---|---|---|---|
|
Change From Baseline to Month 12 in Cerebral Spinal Fluid for Glial Fibrillary Acidic Protein Mean Concentration (pg/mL)
|
-84.946 pg/mL
Standard Deviation 118.736
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 12 other events
Deaths: 1 deaths
Simufilam
Serious events: 25 serious events
Other events: 113 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=77 participants at risk
Subjects from Month 12 to Month 18 that were taking placebo.
Placebo: Matching placebo oral tablets administered b.i.d.
|
Simufilam
n=220 participants at risk
All subjects during day 1 to month 12 (Open-label simufilam), all subjects during month 18 to month 24 (Open-label simufilam), and subjects that were taking simufilam from month 12 to month 18.
Simufilam 100 mg oral tablet: Simufilam 100 mg oral tablet for b.i.d. administration
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/77 • 2 years
|
1.8%
4/220 • Number of events 4 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/77 • Number of events 1 • 2 years
|
0.00%
0/220 • 2 years
|
|
Infections and infestations
COVID-19
|
1.3%
1/77 • Number of events 1 • 2 years
|
0.91%
2/220 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.3%
1/77 • Number of events 1 • 2 years
|
0.00%
0/220 • 2 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.3%
1/77 • Number of events 1 • 2 years
|
0.00%
0/220 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.3%
1/77 • Number of events 1 • 2 years
|
0.00%
0/220 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.3%
1/77 • Number of events 1 • 2 years
|
0.00%
0/220 • 2 years
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
General disorders
Asthenia
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Infections and infestations
Bursitis infective staphylococcal
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/77 • 2 years
|
0.91%
2/220 • Number of events 2 • 2 years
|
|
Infections and infestations
Cystitis
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Infections and infestations
Peritonitis
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/77 • 2 years
|
0.45%
1/220 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Placebo
n=77 participants at risk
Subjects from Month 12 to Month 18 that were taking placebo.
Placebo: Matching placebo oral tablets administered b.i.d.
|
Simufilam
n=220 participants at risk
All subjects during day 1 to month 12 (Open-label simufilam), all subjects during month 18 to month 24 (Open-label simufilam), and subjects that were taking simufilam from month 12 to month 18.
Simufilam 100 mg oral tablet: Simufilam 100 mg oral tablet for b.i.d. administration
|
|---|---|---|
|
Infections and infestations
COVID-19
|
5.2%
4/77 • Number of events 4 • 2 years
|
11.8%
26/220 • Number of events 26 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
3.9%
3/77 • Number of events 3 • 2 years
|
10.0%
22/220 • Number of events 22 • 2 years
|
|
Nervous system disorders
Headache
|
1.3%
1/77 • Number of events 1 • 2 years
|
8.6%
19/220 • Number of events 19 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/77 • 2 years
|
6.4%
14/220 • Number of events 14 • 2 years
|
|
Vascular disorders
Hypertension
|
1.3%
1/77 • Number of events 1 • 2 years
|
5.9%
13/220 • Number of events 13 • 2 years
|
|
Psychiatric disorders
Anxiety
|
1.3%
1/77 • Number of events 1 • 2 years
|
5.9%
13/220 • Number of events 13 • 2 years
|
|
Psychiatric disorders
Insomnia
|
2.6%
2/77 • Number of events 2 • 2 years
|
5.0%
11/220 • Number of events 11 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place