Trial Outcomes & Findings for A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease (NCT NCT05744401)
NCT ID: NCT05744401
Last Updated: 2026-02-25
Results Overview
Adverse Events are any untoward medical occurrence in a participant enrolled in this study, including side effects, injury, toxicity, sensitivity reaction, intercurrent illnesses, clinically significant physical exam signs, or sudden death, whether or not it is considered related to the study drug.
TERMINATED
PHASE2
197 participants
From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks.
2026-02-25
Participant Flow
This was a long term extension to the AL002-2 parent study, where participants were required to complete the planned treatment period in AL002-2.
Participants received AL002 at final doses of 15 mg/kg, 40 mg/kg, or 60 mg/kg in the parent study. Participants who were randomized to active treatment in the parent study (Study AL002-2) remained at their previously assigned dose during this long-term extension study. Participants who were randomized to the placebo group in the parent study (Study AL002-2) were enrolled into the Titration Cohort
Participant milestones
| Measure |
AL002 15 mg/kg
Subjects are receiving 15 mg/kg of AL002 every 4 weeks
|
AL002 40 mg/kg
Subjects are receiving 40 mg/kg of AL002 every 4 weeks
|
AL002 60 mg/kg
Subjects are receiving 60 mg/kg of AL002 every 4 weeks
|
Titration Cohort
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
49
|
43
|
64
|
|
Overall Study
COMPLETED
|
4
|
7
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
37
|
42
|
38
|
61
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
AL002 15 mg/kg
n=89 Participants
Subjects are receiving 15 mg/kg of AL002 every 4 weeks
|
AL002 40 mg/kg
n=87 Participants
Subjects are receiving 40 mg/kg of AL002 every 4 weeks
|
AL002 60 mg/kg
n=92 Participants
Subjects are receiving 60 mg/kg of AL002 every 4 weeks
|
Titration Cohort
n=64 Participants
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit)
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=24 Participants
|
24 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
9 Participants
n=565 Participants
|
72 Participants
n=349 Participants
|
|
Age, Categorical
>=65 years
|
66 Participants
n=24 Participants
|
63 Participants
n=20 Participants
|
76 Participants
n=40 Participants
|
55 Participants
n=565 Participants
|
260 Participants
n=349 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=24 Participants
|
49 Participants
n=20 Participants
|
44 Participants
n=40 Participants
|
28 Participants
n=565 Participants
|
164 Participants
n=349 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=24 Participants
|
38 Participants
n=20 Participants
|
48 Participants
n=40 Participants
|
36 Participants
n=565 Participants
|
168 Participants
n=349 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
2 Participants
n=349 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
3 Participants
n=349 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=24 Participants
|
85 Participants
n=20 Participants
|
87 Participants
n=40 Participants
|
62 Participants
n=565 Participants
|
314 Participants
n=349 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=565 Participants
|
1 Participants
n=349 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=565 Participants
|
12 Participants
n=349 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=24 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=565 Participants
|
16 Participants
n=349 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=24 Participants
|
79 Participants
n=20 Participants
|
85 Participants
n=40 Participants
|
61 Participants
n=565 Participants
|
304 Participants
n=349 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
12 Participants
n=349 Participants
|
|
Age, Customized
Mean age of the study participants
|
69.7 Years
STANDARD_DEVIATION 8.26 • n=24 Participants
|
69.2 Years
STANDARD_DEVIATION 7.93 • n=20 Participants
|
70.7 Years
STANDARD_DEVIATION 7.37 • n=40 Participants
|
72.8 Years
STANDARD_DEVIATION 7.48 • n=565 Participants
|
70.4 Years
STANDARD_DEVIATION 7.86 • n=349 Participants
|
PRIMARY outcome
Timeframe: From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks.Adverse Events are any untoward medical occurrence in a participant enrolled in this study, including side effects, injury, toxicity, sensitivity reaction, intercurrent illnesses, clinically significant physical exam signs, or sudden death, whether or not it is considered related to the study drug.
Outcome measures
| Measure |
AL002 15 mg/kg
n=41 Participants
Subjects are receiving 15 mg/kg of AL002 every 4 weeks
|
AL002 40 mg/kg
n=49 Participants
Subjects are receiving 40 mg/kg of AL002 every 4 weeks
|
AL002 60 mg/kg
n=43 Participants
Subjects are receiving 60 mg/kg of AL002 every 4 weeks
|
Titration Cohort
n=64 Participants
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit)
|
|---|---|---|---|---|
|
Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).
TEAE: Death
|
0 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
1 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
|
Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).
TEAE: Severe
|
1 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
2 Occurrence of Adverse Event
|
4 Occurrence of Adverse Event
|
|
Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).
TEAE: Moderate
|
5 Occurrence of Adverse Event
|
3 Occurrence of Adverse Event
|
11 Occurrence of Adverse Event
|
11 Occurrence of Adverse Event
|
|
Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).
TEAE: Mild
|
10 Occurrence of Adverse Event
|
17 Occurrence of Adverse Event
|
19 Occurrence of Adverse Event
|
21 Occurrence of Adverse Event
|
|
Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).
Treatment-Related TEAE: Death
|
0 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
|
Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).
Treatment-Related TEAE: Severe
|
1 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
2 Occurrence of Adverse Event
|
|
Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).
Treatment-Related TEAE: Moderate
|
2 Occurrence of Adverse Event
|
1 Occurrence of Adverse Event
|
2 Occurrence of Adverse Event
|
4 Occurrence of Adverse Event
|
|
Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).
Treatment-Related TEAE: Mild
|
1 Occurrence of Adverse Event
|
4 Occurrence of Adverse Event
|
7 Occurrence of Adverse Event
|
10 Occurrence of Adverse Event
|
PRIMARY outcome
Timeframe: From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks.Adverse Events are any untoward medical occurrence in a participant enrolled in this study, including side effects, injury, toxicity, sensitivity reaction, intercurrent illnesses, clinically significant physical exam signs, or sudden death, whether or not it is considered related to the study drug.
Outcome measures
| Measure |
AL002 15 mg/kg
n=41 Participants
Subjects are receiving 15 mg/kg of AL002 every 4 weeks
|
AL002 40 mg/kg
n=49 Participants
Subjects are receiving 40 mg/kg of AL002 every 4 weeks
|
AL002 60 mg/kg
n=43 Participants
Subjects are receiving 60 mg/kg of AL002 every 4 weeks
|
Titration Cohort
n=64 Participants
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit)
|
|---|---|---|---|---|
|
Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events
Treatment-Emergent Adverse Event of Special Interest
|
2 Occurrence of Adverse Event
|
2 Occurrence of Adverse Event
|
5 Occurrence of Adverse Event
|
11 Occurrence of Adverse Event
|
|
Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events
Treatment-Related Adverse Events of Special Interest
|
2 Occurrence of Adverse Event
|
2 Occurrence of Adverse Event
|
5 Occurrence of Adverse Event
|
11 Occurrence of Adverse Event
|
|
Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events
Treatment-Emergent Serious Adverse Event (TESAE)
|
0 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
3 Occurrence of Adverse Event
|
7 Occurrence of Adverse Event
|
|
Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events
Treatment-Related Serious Adverse Event
|
0 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
0 Occurrence of Adverse Event
|
3 Occurrence of Adverse Event
|
PRIMARY outcome
Timeframe: From the Screening period and throughout the treatment period until the end of study completion, up to 49 weeksEvaluation of vital signs (blood pressure, pulse, temperature), clinical laboratory results (hematology, biochemistry, urinalysis), and findings from physical, neurological, ophthalmological examinations, and electrocardiograms.
Outcome measures
| Measure |
AL002 15 mg/kg
n=41 Participants
Subjects are receiving 15 mg/kg of AL002 every 4 weeks
|
AL002 40 mg/kg
n=49 Participants
Subjects are receiving 40 mg/kg of AL002 every 4 weeks
|
AL002 60 mg/kg
n=43 Participants
Subjects are receiving 60 mg/kg of AL002 every 4 weeks
|
Titration Cohort
n=64 Participants
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit)
|
|---|---|---|---|---|
|
Safety and Tolerability as Measured by the Number of Cases of Abnormal Vital Signs, Clinical Laboratory Results and Findings From Physical, Neurological, Ophthalmological Examinations and Electrocardiograms.
|
0 Occurrence of Abnormal Findings
|
0 Occurrence of Abnormal Findings
|
0 Occurrence of Abnormal Findings
|
0 Occurrence of Abnormal Findings
|
PRIMARY outcome
Timeframe: From the Screening period and throughout the treatment period until the end of the study participation up to 49 weeks.Two versions of the C-SSRS were used in the parent study: a Screening/Baseline version and a Since Last Visit version. The Screening/Baseline version of the C-SSRS assesses the lifetime suicidal ideation and behavior and non-suicidal self-injurious behavior, the suicidal ideation in the past 6 months, and suicidal behavior and non-suicidal self-injurious behavior in the past two years. The C-SSRS uses a point scale where a higher score indicates a greater risk of suicidality.
Outcome measures
| Measure |
AL002 15 mg/kg
n=41 Participants
Subjects are receiving 15 mg/kg of AL002 every 4 weeks
|
AL002 40 mg/kg
n=49 Participants
Subjects are receiving 40 mg/kg of AL002 every 4 weeks
|
AL002 60 mg/kg
n=43 Participants
Subjects are receiving 60 mg/kg of AL002 every 4 weeks
|
Titration Cohort
n=64 Participants
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit)
|
|---|---|---|---|---|
|
To Evaluate the Long-term Safety and Tolerability of AL002, by Assessing the Number of Suicidal Risk Events Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
|
1 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
PRIMARY outcome
Timeframe: Screening, Week 9, Week 17, Week 25, Week 33, Week 41, End of Study visit, and Early Termination visit, if applicable up to 49 weeksPopulation: The analysis population for this outcome includes the parent study and the long term extension.
Among the brain abnormalities detected on MRI are ARIA, which are believed to reflect leakage of proteinaceous fluid or other blood products in the leptomeninges or brain parenchyma. The term ARIA was originally coined to describe specific brain abnormalities seen on MRI in anti-amyloid clinical trials. Specifically, according to the convention developed to describe ARIA occurring in clinical trials of anti-amyloid immunotherapies, ARIA-E refers to MRI findings of vasogenic edema and leptomeningeal/sulcal effusion.
Outcome measures
| Measure |
AL002 15 mg/kg
n=97 Participants
Subjects are receiving 15 mg/kg of AL002 every 4 weeks
|
AL002 40 mg/kg
n=94 Participants
Subjects are receiving 40 mg/kg of AL002 every 4 weeks
|
AL002 60 mg/kg
n=77 Participants
Subjects are receiving 60 mg/kg of AL002 every 4 weeks
|
Titration Cohort
n=64 Participants
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit)
|
|---|---|---|---|---|
|
To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-E by Assessing the Number of Participants With ARIA-E Events
|
23 Number of Participants
|
23 Number of Participants
|
17 Number of Participants
|
7 Number of Participants
|
PRIMARY outcome
Timeframe: Screening, Week 9, Week 17, Week 25, Week 33, Week 41, End of Study visit, and Early Termination visit, if applicable up to 49 weeksPopulation: The analysis population for this outcome includes the parent study and the long term extension.
Among the brain abnormalities detected on MRI are ARIA, which are believed to reflect leakage of proteinaceous fluid or other blood products int the leptomeninges or brain parenchyma. The term ARIA was originally coined to describe specific brain abnormalities seen on MRI in anti-amyloid clinical trials. Specifically, according to the convention developed to describe ARIA occurring in clinical trials of anti-amyloid immunotherapies, ARIA-H refers to MRI findings of cerebral microhemorrhages, leptomeningeal hemosiderosis, and cerebral macrohemorrhages.
Outcome measures
| Measure |
AL002 15 mg/kg
n=97 Participants
Subjects are receiving 15 mg/kg of AL002 every 4 weeks
|
AL002 40 mg/kg
n=94 Participants
Subjects are receiving 40 mg/kg of AL002 every 4 weeks
|
AL002 60 mg/kg
n=77 Participants
Subjects are receiving 60 mg/kg of AL002 every 4 weeks
|
Titration Cohort
n=64 Participants
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit)
|
|---|---|---|---|---|
|
To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events
Incidence of ARIA-H
|
30 Number of Participants
|
30 Number of Participants
|
25 Number of Participants
|
9 Number of Participants
|
|
To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events
Incidence of Microhemorrhages
|
17 Number of Participants
|
18 Number of Participants
|
18 Number of Participants
|
6 Number of Participants
|
|
To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events
Incidence of Superficial Siderosis
|
12 Number of Participants
|
12 Number of Participants
|
6 Number of Participants
|
2 Number of Participants
|
|
To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events
Incidence of Macrohemorrhages
|
1 Number of Participants
|
0 Number of Participants
|
1 Number of Participants
|
1 Number of Participants
|
Adverse Events
AL002 15 mg/kg
AL002 40 mg/kg
AL002 60 mg/kg
Titration Cohort
Serious adverse events
| Measure |
AL002 15 mg/kg
n=41 participants at risk
Subjects are receiving 15 mg/kg of AL002 every 4 weeks
|
AL002 40 mg/kg
n=49 participants at risk
Subjects are receiving 40 mg/kg of AL002 every 4 weeks
|
AL002 60 mg/kg
n=43 participants at risk
Subjects are receiving 60 mg/kg of AL002 every 4 weeks
|
Titration Cohort
n=64 participants at risk
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit)
|
|---|---|---|---|---|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Myeloma
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Nervous system disorders
Amyloid-related Imaging Abnormality: Microhaemorrhages and Haemosiderin Deposits
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
Other adverse events
| Measure |
AL002 15 mg/kg
n=41 participants at risk
Subjects are receiving 15 mg/kg of AL002 every 4 weeks
|
AL002 40 mg/kg
n=49 participants at risk
Subjects are receiving 40 mg/kg of AL002 every 4 weeks
|
AL002 60 mg/kg
n=43 participants at risk
Subjects are receiving 60 mg/kg of AL002 every 4 weeks
|
Titration Cohort
n=64 participants at risk
The titration cohort will receive an initial starting dose of 6 mg/kg that will be increased to the target dose of 60 mg/kg. The subject will receive two doses of 6 mg/kg (Day 1/Week 1 and Week 5). The subject will receive two doses of 15 mg/kg (Week 9 and Week 13). The subject will receive two doses of 40 mg/kg (Week 17 and Week 21). Lastly, the subject will receive a dose of 60 mg/kg for the remainder of the study (Week 25 through the final dosing visit)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Eye disorders
Blepharitis
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
4.7%
2/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Eye disorders
Macular Degeneration
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Eye disorders
Cataract
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Eye disorders
Cystoid Macular Oedema
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.0%
1/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Eye disorders
Detachment of Macular Retinal Pigment Epithelium
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Eye disorders
Neovascular Age-related Macular Degeneration
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Eye disorders
Pseudophakia
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Eye disorders
Retinal Artery Embolism
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Eye disorders
Visual Acuity Reduced
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
6.1%
3/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
9.3%
4/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
3.1%
2/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
6.1%
3/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
7.0%
3/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
General disorders
Toothache
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.0%
1/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
General disorders
Malaise
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
4.1%
2/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
4.7%
2/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
3.1%
2/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
4.7%
2/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
6.2%
4/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.9%
2/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.0%
1/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.0%
1/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
7.0%
3/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
4.7%
3/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
Skin Infection
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
4.7%
2/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
4.7%
3/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Infusion-related Reaction
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
4.7%
2/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
4.7%
3/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
Amylase Increased
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
3.1%
2/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
Weight Increased
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
4.7%
2/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
Aspartate Aminotransferase Increased
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
Blood Cholesterol Increases
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
Coagulation Test Abnormal
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
Columbia-Suicide Severity Rating Scale Abnormal
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
Weight Decreased
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Metabolism and nutrition disorders
Gout
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Metabolism and nutrition disorders
Dyslipidemia
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Metabolism and nutrition disorders
Hyperhomocystenaemia
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
1.6%
1/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
2.4%
1/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Myeloma
|
0.00%
0/41 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/49 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
2.3%
1/43 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
0.00%
0/64 • Adverse events were collected from the time the participant signed the informed consent form until the end of study participation up to 57 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Alector's agreements with principal investigators may vary but will not prohibit any investigator from publishing. Alector supports the publication of the results from all centers in a multi-center trial, and its agreements include provisions to enable the multi-center publication to occur before publication of data from a single site.
- Publication restrictions are in place
Restriction type: OTHER