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TerminatedPhase 3Results posted

A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)

An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease

Lead sponsor

Hoffmann-La Roche

Asset

Gantenerumab

Listed sites

268

Recruiting sites

-

Enrollment

1,382

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoints

•At Least One Adverse Event (AE) and Serious Adverse Event (SAE)•Post-baseline Suicidal Ideation or Suicidal Behavior as Measured•At Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2020-000766-42
NCT IDNCT04374253
Org study IDWN42171

Timeline

Milestones

Study first posted2020-05-05actual
Study start2021-01-26actual
Primary completion2023-03-06actual
Study completion2023-03-06actual
Last update posted2024-05-08actual
Results first posted2024-05-08actual

Assets

Drug assets

Gantenerumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Completed Study WN29922 or WN39658, either its double-blind part or OLE part, and did not discontinue study drug early
•The participant should be capable of completing assessments either alone or with the help of the caregiver
•Availability of a person (referred to as the "caregiver")
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of <1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab
•Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug

Exclusion criteria

•Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
•Prematurely discontinued from Study WN29922 or WN39658
•Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
•Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part
•Evidence of disseminated leptomeningeal hemosiderosis
•Evidence of intracerebral macrohemorrhage
•Use of prohibited medication
•Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part

Endpoints (34)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
8
Other (unclassified)
6
Memory
4
Function / daily living
4
Amyloid biomarkers
4
Safety / tolerability / PK
4
Executive function / language
2
Behavior / neuropsychiatric
2

Global cognition

8 endpoints
Secondary/protocol endpoint

Change From Baseline Over Time in Clinical Dementia Rating - Global Score (CDR-GS)

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in Clinical Dementia Rating (CDR) - Sum of Boxes (SB)

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in Clinical Dementia Rating - Global Score (CDR-GS)

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebo: Participated in Graduate OLEChange from Baseline at Week 24n=15 Participants0.40.50
Change from Baseline at Week 36n=5 Participants0.40.55
Change from Baseline at Week 52n=14 Participants0.30.46
Change from Baseline at Week 76n=11 Participants0.50.69
Change from Baseline at Week 104n=5 Participants0.60.89
Placebo: No Participation in Graduate OLEChange from Baseline at Week 24n=611 Participants0.10.43
Change from Baseline at Week 36n=107 Participants0.30.55
Change from Baseline at Week 52n=336 Participants0.20.44
Change from Baseline at Week 76n=169 Participants0.30.47
Change from Baseline at Week 104n=19 Participants0.60.52
Gantenerumab: Participated in Graduate OLEChange from Baseline at Week 24n=25 Participants0.10.53
Change from Baseline at Week 36n=9 Participants0.10.42
Change from Baseline at Week 52n=20 Participants-0.10.43
Change from Baseline at Week 76n=19 Participants0.20.75
Change from Baseline at Week 104n=13 Participants0.20.43
Gantenerumab: No Participation in Graduate OLEChange from Baseline at Week 24n=561 Participants0.10.41
Change from Baseline at Week 36n=89 Participants0.20.47
Change from Baseline at Week 52n=327 Participants0.20.46
Change from Baseline at Week 76n=161 Participants0.30.44
Change from Baseline at Week 104n=20 Participants0.30.50
Secondary/registry result

Change From Baseline Over Time in Clinical Dementia Rating (CDR) - Sum of Boxes (SB)

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebo: Participated in Graduate OLEChange from Baseline at Week 24n=15 Participants2.102.473
Change from Baseline at Week 36n=5 Participants2.902.608
Change from Baseline at Week 52n=14 Participants2.572.286
Change from Baseline at Week 76n=11 Participants2.683.133
Change from Baseline at Week 104n=5 Participants3.803.213
Placebo: No Participation in Graduate OLEChange from Baseline at Week 24n=611 Participants0.831.787
Change from Baseline at Week 36n=107 Participants1.392.397
Change from Baseline at Week 52n=336 Participants1.601.906
Change from Baseline at Week 76n=169 Participants2.201.994
Change from Baseline at Week 104n=19 Participants3.262.751
Gantenerumab: Participated in Graduate OLEChange from Baseline at Week 24n=25 Participants1.002.529
Change from Baseline at Week 36n=9 Participants0.722.265
Change from Baseline at Week 52n=20 Participants0.801.351
Change from Baseline at Week 76n=19 Participants1.953.218
Change from Baseline at Week 104n=13 Participants1.152.470
Gantenerumab: No Participation in Graduate OLEChange from Baseline at Week 24n=561 Participants0.701.754
Change from Baseline at Week 36n=89 Participants1.112.161
Change from Baseline at Week 52n=327 Participants1.502.051
Change from Baseline at Week 76n=161 Participants1.972.249
Change from Baseline at Week 104n=20 Participants1.801.949
Secondary/registry result

Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebo: Participated in Graduate OLEChange from Baseline at Week 24n=15 Participants-0.32.41
Change from Baseline at Week 36n=5 Participants-1.83.35
Change from Baseline at Week 52n=15 Participants-1.92.94
Change from Baseline at Week 76n=12 Participants-2.93.20
Change from Baseline at Week 104n=5 Participants-3.65.13
Placebo: No Participation in Graduate OLEChange from Baseline at Week 24n=622 Participants-1.22.87
Change from Baseline at Week 36n=111 Participants-1.62.83
Change from Baseline at Week 52n=346 Participants-2.33.15
Change from Baseline at Week 76n=173 Participants-3.23.39
Change from Baseline at Week 104n=19 Participants-4.33.93
Gantenerumab: Participated in Graduate OLEChange from Baseline at Week 24n=27 Participants-0.92.39
Change from Baseline at Week 36n=9 Participants-0.31.66
Change from Baseline at Week 52n=21 Participants-2.03.49
Change from Baseline at Week 76n=20 Participants-2.93.97
Change from Baseline at Week 104n=14 Participants-2.93.92
Gantenerumab: No Participation in Graduate OLEChange from Baseline at Week 24n=571 Participants-1.12.69
Change from Baseline at Week 36n=93 Participants-1.73.18
Change from Baseline at Week 52n=337 Participants-2.13.14
Change from Baseline at Week 76n=165 Participants-3.03.56
Change from Baseline at Week 104n=21 Participants-3.04.12
Secondary/registry result

Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebo: Participated in Graduate OLEChange from Baseline at Week 24n=14 Participants2.96.29
Change from Baseline at Week 36n=5 Participants13.211.52
Change from Baseline at Week 52n=14 Participants6.710.13
Change from Baseline at Week 76n=11 Participants7.911.89
Change from Baseline at Week 104n=5 Participants10.414.98
Placebo: No Participation in Graduate OLEChange from Baseline at Week 24n=597 Participants3.05.73
Change from Baseline at Week 36n=104 Participants4.77.05
Change from Baseline at Week 52n=325 Participants4.36.45
Change from Baseline at Week 76n=164 Participants6.87.85
Change from Baseline at Week 104n=19 Participants8.78.13
Gantenerumab: Participated in Graduate OLEChange from Baseline at Week 24n=27 Participants2.05.53
Change from Baseline at Week 36n=9 Participants-3.45.39
Change from Baseline at Week 52n=20 Participants2.76.01
Change from Baseline at Week 76n=20 Participants7.79.76
Change from Baseline at Week 104n=13 Participants4.86.74
Gantenerumab: No Participation in Graduate OLEChange from Baseline at Week 24n=542 Participants3.35.45
Change from Baseline at Week 36n=84 Participants4.75.85
Change from Baseline at Week 52n=319 Participants5.36.94
Change from Baseline at Week 76n=161 Participants6.78.22
Change from Baseline at Week 104n=22 Participants8.810.22

Memory

4 endpoints
Secondary/protocol endpoint

Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in Coding (Digit Symbol Substitution Test [DSST]) Subset

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebo: Participated in Graduate OLEChange from Baseline at Week 24n=14 Participants2.45.56
Change from Baseline at Week 36n=5 Participants12.010.00
Change from Baseline at Week 52n=14 Participants5.69.55
Change from Baseline at Week 76n=11 Participants6.610.90
Change from Baseline at Week 104n=5 Participants8.414.12
Placebo: No Participation in Graduate OLEChange from Baseline at Week 24n=611 Participants2.45.47
Change from Baseline at Week 36n=107 Participants3.96.80
Change from Baseline at Week 52n=332 Participants3.76.13
Change from Baseline at Week 76n=170 Participants5.97.52
Change from Baseline at Week 104n=19 Participants7.87.65
Gantenerumab: Participated in Graduate OLEChange from Baseline at Week 24n=27 Participants1.65.29
Change from Baseline at Week 36n=9 Participants-3.75.50
Change from Baseline at Week 52n=20 Participants1.95.89
Change from Baseline at Week 76n=20 Participants7.09.50
Change from Baseline at Week 104n=13 Participants3.86.67
Gantenerumab: No Participation in Graduate OLEChange from Baseline at Week 24n=549 Participants2.85.22
Change from Baseline at Week 36n=86 Participants4.05.46
Change from Baseline at Week 52n=326 Participants4.76.61
Change from Baseline at Week 76n=162 Participants6.17.80
Change from Baseline at Week 104n=22 Participants8.210.26
Secondary/registry result

Change From Baseline Over Time in Coding (Digit Symbol Substitution Test [DSST]) Subset

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebo: Participated in Graduate OLEChange from Baseline at Week 24n=14 Participants-0.56.31
Change from Baseline at Week 36n=5 Participants-8.010.00
Change from Baseline at Week 52n=15 Participants-3.17.61
Change from Baseline at Week 76n=11 Participants-3.48.49
Change from Baseline at Week 104n=5 Participants0.49.94
Placebo: No Participation in Graduate OLEChange from Baseline at Week 24n=617 Participants-2.87.84
Change from Baseline at Week 36n=107 Participants-4.88.09
Change from Baseline at Week 52n=343 Participants-5.08.60
Change from Baseline at Week 76n=171 Participants-7.210.12
Change from Baseline at Week 104n=19 Participants-4.513.25
Gantenerumab: Participated in Graduate OLEChange from Baseline at Week 24n=27 Participants-0.39.02
Change from Baseline at Week 36n=9 Participants6.213.96
Change from Baseline at Week 52n=20 Participants-2.814.00
Change from Baseline at Week 76n=19 Participants-7.18.99
Change from Baseline at Week 104n=13 Participants-5.211.95
Gantenerumab: No Participation in Graduate OLEChange from Baseline at Week 24n=563 Participants-2.38.04
Change from Baseline at Week 36n=89 Participants-3.09.66
Change from Baseline at Week 52n=333 Participants-4.78.79
Change from Baseline at Week 76n=164 Participants-6.09.71
Change from Baseline at Week 104n=21 Participants-7.011.04

Executive function / language

2 endpoints
Secondary/protocol endpoint

Change From Baseline Over Time in Verbal Fluency Task Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in Verbal Fluency Task Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebo: Participated in Graduate OLEChange from Baseline at Week 24n=15 Participants0.22.73
Change from Baseline at Week 36n=5 Participants-2.23.42
Change from Baseline at Week 52n=15 Participants-1.53.02
Change from Baseline at Week 76n=12 Participants-1.32.83
Change from Baseline at Week 104n=5 Participants-0.64.22
Placebo: No Participation in Graduate OLEChange from Baseline at Week 24n=622 Participants-0.93.15
Change from Baseline at Week 36n=108 Participants-1.23.07
Change from Baseline at Week 52n=346 Participants-1.53.60
Change from Baseline at Week 76n=176 Participants-2.13.66
Change from Baseline at Week 104n=19 Participants-3.83.79
Gantenerumab: Participated in Graduate OLEChange from Baseline at Week 24n=27 Participants-1.02.83
Change from Baseline at Week 36n=9 Participants-0.62.70
Change from Baseline at Week 52n=20 Participants-0.42.39
Change from Baseline at Week 76n=19 Participants-1.34.36
Change from Baseline at Week 104n=13 Participants-0.84.09
Gantenerumab: No Participation in Graduate OLEChange from Baseline at Week 24n=567 Participants-0.64.73
Change from Baseline at Week 36n=90 Participants-1.43.45
Change from Baseline at Week 52n=337 Participants-1.55.77
Change from Baseline at Week 76n=164 Participants-2.87.54
Change from Baseline at Week 104n=21 Participants-3.32.50

Function / daily living

4 endpoints
Secondary/protocol endpoint

Change in Functional Activities Questionnaire (FAQ) Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

change from baseline, improvement

Secondary/protocol endpoint

Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change in Functional Activities Questionnaire (FAQ) Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebo: Participated in Graduate OLEChange from Baseline at Week 24n=15 Participants1.24.04
Change from Baseline at Week 36n=5 Participants-1.01.87
Change from Baseline at Week 52n=14 Participants2.13.80
Change from Baseline at Week 76n=13 Participants2.33.66
Change from Baseline at Week 104n=5 Participants3.24.92
Placebo: No Participation in Graduate OLEChange from Baseline at Week 24n=618 Participants1.64.36
Change from Baseline at Week 36n=111 Participants2.75.07
Change from Baseline at Week 52n=346 Participants2.64.39
Change from Baseline at Week 76n=172 Participants4.04.55
Change from Baseline at Week 104n=17 Participants4.54.09
Gantenerumab: Participated in Graduate OLEChange from Baseline at Week 24n=25 Participants0.13.15
Change from Baseline at Week 36n=9 Participants1.36.18
Change from Baseline at Week 52n=19 Participants2.73.73
Change from Baseline at Week 76n=20 Participants3.33.95
Change from Baseline at Week 104n=13 Participants4.14.91
Gantenerumab: No Participation in Graduate OLEChange from Baseline at Week 24n=568 Participants1.54.09
Change from Baseline at Week 36n=96 Participants1.74.92
Change from Baseline at Week 52n=333 Participants2.64.81
Change from Baseline at Week 76n=162 Participants3.55.12
Change from Baseline at Week 104n=21 Participants1.75.07
Secondary/registry result

Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score

Time frame:Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

GroupValue (mean), score on a scaleStandard deviation
Placebo: Participated in Graduate OLEChange from Baseline at Week 24n=15 Participants-4.75.15
Change from Baseline at Week 36n=4 Participants-12.512.40
Change from Baseline at Week 52n=14 Participants-9.47.49
Change from Baseline at Week 76n=13 Participants-10.811.19
Change from Baseline at Week 104n=5 Participants-11.617.99
Placebo: No Participation in Graduate OLEChange from Baseline at Week 24n=618 Participants-2.97.07
Change from Baseline at Week 36n=111 Participants-5.69.55
Change from Baseline at Week 52n=344 Participants-5.98.97
Change from Baseline at Week 76n=172 Participants-7.89.87
Change from Baseline at Week 104n=17 Participants-6.610.20
Gantenerumab: Participated in Graduate OLEChange from Baseline at Week 24n=25 Participants-2.07.10
Change from Baseline at Week 36n=9 Participants-2.16.23
Change from Baseline at Week 52n=19 Participants-4.48.09
Change from Baseline at Week 76n=20 Participants-8.311.22
Change from Baseline at Week 104n=13 Participants-6.313.52
Gantenerumab: No Participation in Graduate OLEChange from Baseline at Week 24n=569 Participants-3.26.69
Change from Baseline at Week 36n=96 Participants-4.98.53
Change from Baseline at Week 52n=334 Participants-6.28.38
Change from Baseline at Week 76n=162 Participants-6.99.62
Change from Baseline at Week 104n=21 Participants-9.912.21

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Primary/registry result

Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebo: Participated in Graduate OLESuicidal Ideation: Passiven=14 Participants1-
Suicidal Ideation: Active-Nonspecific (No Method, Intent, or Plan)n=14 Participants0-
Suicidal Ideation: Active-Method, but No Intent or Plann=14 Participants1-
Suicidal Ideation: No eventn=14 Participants12-
Suicidal Behavior: Completed Suiciden=14 Participants0-
Suicidal Behavior: Aborted Attemptn=14 Participants0-
Suicidal Behavior: Preparatory Actions Toward Imminent Suicidal Behaviorsn=14 Participants0-
Suicidal Behavior: No eventn=14 Participants14-
Self-injurious Behavior, Without Suicidal Intent: Self-Injurious Behavior - No Suicidal Intentn=14 Participants0-
Self-Injurious Behavior Without Suicidal Intent: No eventn=14 Participants14-
Placebo: No Participation in Graduate OLESuicidal Ideation: Passiven=631 Participants11-
Suicidal Ideation: Active-Nonspecific (No Method, Intent, or Plan)n=631 Participants3-
Suicidal Ideation: Active-Method, but No Intent or Plann=631 Participants0-
Suicidal Ideation: No eventn=631 Participants617-
Suicidal Behavior: Completed Suiciden=631 Participants0-
Suicidal Behavior: Aborted Attemptn=631 Participants1-
Suicidal Behavior: Preparatory Actions Toward Imminent Suicidal Behaviorsn=631 Participants1-
Suicidal Behavior: No eventn=631 Participants629-
Self-injurious Behavior, Without Suicidal Intent: Self-Injurious Behavior - No Suicidal Intentn=631 Participants2-
Self-Injurious Behavior Without Suicidal Intent: No eventn=631 Participants629-
Gantenerumab: Participated in Graduate OLESuicidal Ideation: Passiven=29 Participants1-
Suicidal Ideation: Active-Nonspecific (No Method, Intent, or Plan)n=29 Participants0-
Suicidal Ideation: Active-Method, but No Intent or Plann=29 Participants1-
Suicidal Ideation: No eventn=29 Participants27-
Suicidal Behavior: Completed Suiciden=29 Participants0-
Suicidal Behavior: Aborted Attemptn=29 Participants0-
Suicidal Behavior: Preparatory Actions Toward Imminent Suicidal Behaviorsn=29 Participants0-
Suicidal Behavior: No eventn=29 Participants29-
Self-injurious Behavior, Without Suicidal Intent: Self-Injurious Behavior - No Suicidal Intentn=29 Participants0-
Self-Injurious Behavior Without Suicidal Intent: No eventn=29 Participants29-
Gantenerumab: No Participation in Graduate OLESuicidal Ideation: Passiven=588 Participants11-
Suicidal Ideation: Active-Nonspecific (No Method, Intent, or Plan)n=588 Participants2-
Suicidal Ideation: Active-Method, but No Intent or Plann=588 Participants0-
Suicidal Ideation: No eventn=588 Participants575-
Suicidal Behavior: Completed Suiciden=588 Participants2-
Suicidal Behavior: Aborted Attemptn=588 Participants0-
Suicidal Behavior: Preparatory Actions Toward Imminent Suicidal Behaviorsn=588 Participants0-
Suicidal Behavior: No eventn=588 Participants586-
Self-injurious Behavior, Without Suicidal Intent: Self-Injurious Behavior - No Suicidal Intentn=588 Participants0-
Self-Injurious Behavior Without Suicidal Intent: No eventn=588 Participants588-

Amyloid biomarkers

4 endpoints
Primary/protocol endpoint

Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Primary/protocol endpoint

Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Primary/registry result

Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebo: Participated in Graduate OLEn=14 Participants6-
Placebo: No Participation in Graduate OLEn=671 Participants104-
Gantenerumab: Participated in Graduate OLEn=29 Participants5-
Gantenerumab: No Participation in Graduate OLEn=627 Participants27-
Primary/registry result

Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebo: Participated in Graduate OLEn=14 Participants3-
Placebo: No Participation in Graduate OLEn=671 Participants85-
Gantenerumab: Participated in Graduate OLEn=29 Participants4-
Gantenerumab: No Participation in Graduate OLEn=627 Participants40-

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE)

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Primary/protocol endpoint

Number of Participants With at Least One Adverse Event of Special Interest (AESI)

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Primary/registry result

Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE)

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebo: Participated in Graduate OLEAEsn=14 Participants13-
SAEsn=14 Participants2-
Placebo: No Participation in Graduate OLEAEsn=691 Participants510-
SAEsn=691 Participants72-
Gantenerumab: Participated in Graduate OLEAEsn=29 Participants25-
SAEsn=29 Participants4-
Gantenerumab: No Participation in Graduate OLEAEsn=647 Participants487-
SAEsn=647 Participants54-
Primary/registry result

Number of Participants With at Least One Adverse Event of Special Interest (AESI)

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebo: Participated in Graduate OLEn=14 Participants0-
Placebo: No Participation in Graduate OLEn=691 Participants0-
Gantenerumab: Participated in Graduate OLEn=29 Participants0-
Gantenerumab: No Participation in Graduate OLEn=647 Participants0-

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

Number of Participants With Injection-Site Reactions (ISRs)

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Primary/protocol endpoint/low confidence

Number of Participants Who Discontinued the Study Due an AE

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Primary/registry result/low confidence

Number of Participants With Injection-Site Reactions (ISRs)

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebo: Participated in Graduate OLEn=14 Participants3-
Placebo: No Participation in Graduate OLEn=691 Participants63-
Gantenerumab: Participated in Graduate OLEn=29 Participants1-
Gantenerumab: No Participation in Graduate OLEn=647 Participants80-
Primary/registry result/low confidence

Number of Participants Who Discontinued the Study Due an AE

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebo: Participated in Graduate OLEn=14 Participants0-
Placebo: No Participation in Graduate OLEn=691 Participants9-
Gantenerumab: Participated in Graduate OLEn=29 Participants1-
Gantenerumab: No Participation in Graduate OLEn=647 Participants7-
Secondary/protocol endpoint/low confidence

Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Secondary/registry result/low confidence

Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab

Time frame:From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebo: Participated in Graduate OLEn=14 Participants1-
Placebo: No Participation in Graduate OLEn=656 Participants17-
Gantenerumab: Participated in Graduate OLEn=29 Participants1-
Gantenerumab: No Participation in Graduate OLEn=617 Participants14-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.