TerminatedPhase 3Results posted

Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease

Lead sponsor

Hoffmann-La Roche

Asset

Gantenerumab

Listed sites

155

Recruiting sites

Enrollment

975

actual

Study population

Alzheimer’s disease

Key I/E criteria

•prodromal AD•Amyloid biomarker required (PET/CSF)•Tau biomarker required (PET/CSF)•MMSE ≥22•Study partner/caregiver required

Primary endpoints

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)•OLE Period

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 number2017-001365-24

NCT IDNCT03443973

Org study IDWN39658

Timeline

Milestones

Study first posted2018-02-23actual

Study start2018-08-22actual

Primary completion2022-09-23actual

Study completion2022-11-28actual

Last update posted2024-01-17actual

Results first posted2024-01-17actual

Assets

Drug assets

Gantenerumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Key Inclusion criteria:

•Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment)

•Evidence of the AD pathological process, as confirmed by CSF tau/A-beta42or amyloid PET scan

•Demonstrated abnormal memory function

•MMSE score greater than or equal to 22 (≥ 22)

•Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0

•Availability of a reliable study partner who accepts to participate in study procedures throughout the 2 years duration of study

•If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening and until randomization

•For enrollment in the China extension, patients must have residence in mainland China, Hong Kong, or Taiwan and be of Chinese ancestry

•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods

Exclusion criteria

•Any evidence of a condition other than AD that may affect cognition

•History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder

•History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function

•History or presence of clinically evident cerebrovascular disease

•History or presence of posterior reversible encephalopathy syndrome

•History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent with a transient ischemic attack

•History of severe, clinically significant CNS trauma

•History or presence of intracranial mass (e.g., glioma, meningioma) that could potentially impair cognition

•Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae

•History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits

•At risk for suicide in the opinion of the investigator

•Alcohol and/or substance abuse or dependants in past 2 years

•Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities

•Any contraindications to brain MRI

•Unstable or clinically significant cardiovascular, kidney or liver disease

•Uncontrolled hypertension

•Unstable or clinically significant cardiovascular disease

•Abnormal thyroid function

•Patients with evidence of folic acid deficiency

Exclusion for Open-Label Extension (OLE):

•Discontinued from study treatment during the double-blind treatment period

•Received any other investigational medication during the double-blind treatment period or after the end of double-blind treatment

•Participation in the OLE deemed inappropriate by the investigator

•Presence of ARIA-E findings at the Week 116 MRI scan

Endpoints (54)

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

Amyloid biomarkers

Other (unclassified)

Global cognition

Function / daily living

Tau biomarkers

Memory

Behavior / neuropsychiatric

Neurodegeneration biomarkers

Safety / tolerability / PK

Executive function / language

Global cognition

6 endpoints

Primary/protocol endpoint

DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB

Time frame:Baseline, Week 116

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

change from baseline, improvement

Primary/registry result

DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB

Time frame:Baseline, Week 116

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

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebo: DBTn=477 Participants	3.01	0.15
Gantenerumab: DBTn=497 Participants	2.82	0.14

Difference in Adjusted mean-0.1995% CI-0.55 - 0.17p0.2998ANCOVA

Secondary/protocol endpoint

DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score

Time frame:Baseline, Week 116

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score

Time frame:Baseline, Week 116

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score

Time frame:Baseline, Week 116

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebo: DBTn=475 Participants	7.94	0.49
Gantenerumab: DBTn=491 Participants	6.66	0.42

Difference in adjusted mean-1.2895% CI-2.41 - -0.14p0.0273ANCOVA

Secondary/registry result

DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score

Time frame:Baseline, Week 116

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebo: DBTn=477 Participants	-4.53	0.22
Gantenerumab: DBTn=497 Participants	-4.00	0.20

Difference in adjusted mean0.5295% CI-0.01 - 1.06p0.0566ANCOVA

Memory

4 endpoints

Secondary/protocol endpoint

DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score

Time frame:Baseline, Week 116

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

DBT Period: Change From Baseline to Week 116 in the Coding (Digit Symbol Substitution Test [DSST]) Subtest

Time frame:Baseline, Week 116

change from baseline, improvement

Secondary/registry result

DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score

Time frame:Baseline, Week 116

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebo: DBTn=475 Participants	6.97	0.46
Gantenerumab: DBTn=491 Participants	5.77	0.38

Difference in adjusted mean-1.1995% CI-2.24 - -0.14p0.0260ANCOVA

Secondary/registry result

DBT Period: Change From Baseline to Week 116 in the Coding (Digit Symbol Substitution Test [DSST]) Subtest

Time frame:Baseline, Week 116

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebo: DBTn=475 Participants	-6.90	0.59
Gantenerumab: DBTn=497 Participants	-5.49	0.55

Difference in adjusted mean1.4195% CI-0.08 - 2.90p0.0629ANCOVA

Executive function / language

2 endpoints

Secondary/protocol endpoint

DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score

Time frame:Baseline, Week 116

change from baseline, improvement

Secondary/registry result

DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score

Time frame:Baseline, Week 116

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebo: DBTn=477 Participants	-2.68	0.22
Gantenerumab: DBTn=497 Participants	-2.71	0.21

Difference in adjusted mean-0.0395% CI-0.59 - 0.52p0.9086ANCOVA

Function / daily living

6 endpoints

Secondary/protocol endpoint

DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score

Time frame:Baseline, Week 116

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score

Time frame:Baseline, Week 116

change from baseline, improvement

Secondary/protocol endpoint

DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Instrumental Score

Time frame:Baseline, Week 116

change from baseline, improvement

Secondary/registry result

DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score

Time frame:Baseline, Week 116

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebo: DBTn=475 Participants	-9.26	0.62
Gantenerumab: DBTn=496 Participants	-8.44	0.58

Difference in adjusted mean0.8295% CI-0.70 - 2.34p0.2918ANCOVA

Secondary/registry result

DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score

Time frame:Baseline, Week 116

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebo: DBTn=476 Participants	6.72	0.33
Gantenerumab: DBTn=496 Participants	5.86	0.31

Difference in adjusted mean-0.8695% CI-1.70 - -0.02p0.0438ANCOVA

Secondary/registry result

DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Instrumental Score

Time frame:Baseline, Week 116

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebo: DBTn=475 Participants	-8.22	0.53
Gantenerumab: DBTn=496 Participants	-7.43	0.49

Difference in adjusted mean0.7995% CI-0.51 - 2.09p0.2348ANCOVA

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

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

Time frame:From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)

event count, event

Primary/registry result

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

Time frame:From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo (DBT) to Gantenerumab: Open-label Extension (OLE)Suicidal Ideation: Passiven=12 Participants	1	-
Suicidal Ideation: Active-Method, but no Intent or Plann=12 Participants	1	-
Suicidal Ideation: No Eventn=12 Participants	10	-
Suicidal Behavior: No eventn=12 Participants	12	-
Self-injurious Behavior Without Suicidal Intent: No eventn=12 Participants	12	-
Gantenerumab (DBT) to Gantenerumab: OLESuicidal Ideation: Passiven=13 Participants	0	-
Suicidal Ideation: Active-Method, but no Intent or Plann=13 Participants	0	-
Suicidal Ideation: No Eventn=13 Participants	13	-
Suicidal Behavior: No eventn=13 Participants	13	-
Self-injurious Behavior Without Suicidal Intent: No eventn=13 Participants	13	-

Secondary/protocol endpoint

DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Secondary/registry result

DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo: DBTSuicidal Ideation: Passiven=464 Participants	20	-
Suicidal Ideation: Active-Nonspecificn=464 Participants	4	-
Suicidal Ideation: Active-Method, But No Intent or Plann=464 Participants	2	-
Suicidal Ideation: Active-Method and Intent, But No Plann=464 Participants	1	-
Suicidal Ideation: Active-Method, Intent, and Plann=464 Participants	0	-
Suicidal Ideation: No Eventn=464 Participants	437	-
Suicidal Behavior: No Eventn=464 Participants	464	-
Self-injurious Behavior, No Suicidal Intentn=464 Participants	0	-
Self-injurious Behavior Without Suicidal Intent: No Eventn=464 Participants	464	-
Gantenerumab: DBTSuicidal Ideation: Passiven=483 Participants	12	-
Suicidal Ideation: Active-Nonspecificn=483 Participants	2	-
Suicidal Ideation: Active-Method, But No Intent or Plann=483 Participants	2	-
Suicidal Ideation: Active-Method and Intent, But No Plann=483 Participants	1	-
Suicidal Ideation: Active-Method, Intent, and Plann=483 Participants	2	-
Suicidal Ideation: No Eventn=483 Participants	464	-
Suicidal Behavior: No Eventn=483 Participants	483	-
Self-injurious Behavior, No Suicidal Intentn=483 Participants	2	-
Self-injurious Behavior Without Suicidal Intent: No Eventn=483 Participants	481	-

Amyloid biomarkers

10 endpoints

Primary/protocol endpoint

OLE Period : Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI

Time frame:From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)

event count, event

Primary/protocol endpoint

OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)

Time frame:From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)

event count, event

Primary/registry result

OLE Period : Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI

Time frame:From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo (DBT) to Gantenerumab: Open-label Extension (OLE)n=13 Participants	2	-
Gantenerumab (DBT) to Gantenerumab: OLEn=14 Participants	1	-

Primary/registry result

OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)

Time frame:From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo (DBT) to Gantenerumab: Open-label Extension (OLE)n=13 Participants	0	-
Gantenerumab (DBT) to Gantenerumab: OLEn=14 Participants	1	-

Secondary/protocol endpoint

DBT Period: Number of Participants With ARIA-E Confirmed by MRI

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Secondary/protocol endpoint

DBT Period: Number of Participants With ARIA-H Confirmed by MRI

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Secondary/protocol endpoint

Change From Baseline to Week 116 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a Subset of Participants

Time frame:Baseline, Week 116

Amyloid PET Centiloid

change from baseline, improvement

Secondary/registry result

DBT Period: Number of Participants With ARIA-E Confirmed by MRI

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo: DBTn=470 Participants	18	-
Gantenerumab: DBTn=496 Participants	128	-

Secondary/registry result

DBT Period: Number of Participants With ARIA-H Confirmed by MRI

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo: DBTn=470 Participants	57	-
Gantenerumab: DBTn=496 Participants	109	-

Secondary/registry result

Change From Baseline to Week 116 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a Subset of Participants

Time frame:Baseline, Week 116

Amyloid PET Centiloid

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard error
Placebo: DBTn=44 Participants	8.46	2.768
Gantenerumab: DBTn=40 Participants	-48.00	2.845

Difference in adjusted means-56.4695% CI-64.36 - -48.56p<.0001Mixed Model for Repeated Measures

Tau biomarkers

6 endpoints

Secondary/protocol endpoint

Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants

Time frame:Baseline, Week 116

change from baseline, improvement

Secondary/protocol endpoint

DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Total Tau (tTau)

Time frame:Baseline, Week 116

percent change from baseline, improvement

Secondary/protocol endpoint

DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Phosphorylated Tau (pTau-181)

Time frame:Baseline, Week 116

percent change from baseline, improvement

Secondary/registry result

Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants

Time frame:Baseline, Week 116

change from baseline, improvement

Posted result

Group	Value (mean), SUVR	Standard error
Placebo: DBTROI: Temporal Composite Regionn=29 Participants	0.12	0.018
ROI: Medial Temporal Composite Region [not including the Hippocampus]n=29 Participants	0.08	0.014
ROI: Frontal Loben=29 Participants	0.08	0.012
ROI: Parietal Loben=29 Participants	0.09	0.020
Gantenerumab: DBTROI: Temporal Composite Regionn=48 Participants	0.13	0.014
ROI: Medial Temporal Composite Region [not including the Hippocampus]n=48 Participants	0.09	0.011
ROI: Frontal Loben=48 Participants	0.08	0.009
ROI: Parietal Loben=48 Participants	0.09	0.016

Difference in adjusted mean0.0195% CI-0.04 - 0.05p0.7816Mixed Model for Repeated Measures

Difference in adjusted means0.0195% CI-0.03 - 0.05p0.6203Mixed Model for Repeated Measures

Difference in adjusted means0.0095% CI-0.03 - 0.03p0.7754Mixed Model for Repeated Measures

Difference in adjusted means0.0095% CI-0.05 - 0.05p0.9022Mixed Model for Repeated Measures

Secondary/registry result

DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Total Tau (tTau)

Time frame:Baseline, Week 116

percent change from baseline, improvement

Posted result

Group	Value (geometric_mean), percent change in tTau	Reported bounds
Placebo: DBTn=72 Participants	1.8	--4.46 - 8.45
Gantenerumab: DBTn=71 Participants	-16.4	--21.55 - -10.87

Percent Difference in Geometric Mean-17.895% CI-24.92 - -10.11p<0.001ANCOVA

Secondary/registry result

DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Phosphorylated Tau (pTau-181)

Time frame:Baseline, Week 116

percent change from baseline, improvement

Posted result

Group	Value (geometric_mean), percent change in pTau-181	Reported bounds
Placebo: DBTn=71 Participants	0.1	--6.50 - 7.16
Gantenerumab: DBTn=70 Participants	-20.9	--26.17 - -15.31

Percent Difference in Geometric Mean-21.095% CI-28.29 - -12.97p<0.001ANCOVA

Neurodegeneration biomarkers

4 endpoints

Secondary/protocol endpoint

DBT Period: Percent Change From Baseline to Week 116 in Cerebrospinal Fluid (CSF) Marker of Disease in a Subset of Participants - Neurofilament Light Chain (NFL)

Time frame:Baseline, Week 116

Neurofilament light (NfL)

percent change from baseline, improvement

Secondary/protocol endpoint

DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurogranin

Time frame:Baseline, Week 116

percent change from baseline, improvement

Secondary/registry result

DBT Period: Percent Change From Baseline to Week 116 in Cerebrospinal Fluid (CSF) Marker of Disease in a Subset of Participants - Neurofilament Light Chain (NFL)

Time frame:Baseline, Week 116

Neurofilament light (NfL)

percent change from baseline, improvement

Posted result

Group	Value (geometric_mean), percent change in NFL	Reported bounds
Placebo: DBTn=72 Participants	25.5	-15.83 - 35.97
Gantenerumab: DBTn=74 Participants	8.9	-0.60 - 17.83

Percent Difference in Geometric Mean-13.295% CI-22.51 - -2.87p0.014ANCOVA

Secondary/registry result

DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurogranin

Time frame:Baseline, Week 116

percent change from baseline, improvement

Posted result

Group	Value (geometric_mean), percent change in neurogranin	Reported bounds
Placebo: DBTn=72 Participants	-6.1	--11.99 - 0.12
Gantenerumab: DBTn=72 Participants	-19.6	--24.66 - -14.30

Percent Difference in Geometric Mean-14.495% CI-21.88 - -6.21p<0.001ANCOVA

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

OLE Period: Number of Participants With Adverse Events (AEs)

Time frame:From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)

event count, event

Primary/registry result

OLE Period: Number of Participants With Adverse Events (AEs)

Time frame:From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo (DBT) to Gantenerumab: Open-label Extension (OLE)n=13 Participants	8	-
Gantenerumab (DBT) to Gantenerumab: OLEn=14 Participants	6	-

Other/protocol endpoint

Plasma Concentration of Gantenerumab

Time frame:Pre-dose on Days 1, Weeks 24, 52 and 76; Post-dose on Day 4, Weeks 41, 103, and 115

concentration, descriptive

Other_pre_specified/registry result

Plasma Concentration of Gantenerumab

Time frame:Pre-dose on Days 1, Weeks 24, 52 and 76; Post-dose on Day 4, Weeks 41, 103, and 115

concentration, descriptive

Other (unclassified)

8 endpoints

Primary/protocol endpoint/low confidence

OLE Period: Number of Participants With Injection-Site Reactions

Time frame:From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)

event count, event

Primary/registry result/low confidence

OLE Period: Number of Participants With Injection-Site Reactions

Time frame:From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo (DBT) to Gantenerumab: Open-label Extension (OLE)n=13 Participants	0	-
Gantenerumab (DBT) to Gantenerumab: OLEn=14 Participants	1	-

Secondary/protocol endpoint/low confidence

DBT Period: Number of Participants With AEs

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Secondary/protocol endpoint/low confidence

DBT Period: Number of Participants With Injection-Site Reactions

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Secondary/protocol endpoint/low confidence

DBT Period: Number of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Secondary/registry result/low confidence

DBT Period: Number of Participants With AEs

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo: DBTn=474 Participants	409	-
Gantenerumab: DBTn=501 Participants	451	-

Secondary/registry result/low confidence

DBT Period: Number of Participants With Injection-Site Reactions

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo: DBTn=474 Participants	31	-
Gantenerumab: DBTn=501 Participants	75	-

Secondary/registry result/low confidence

DBT Period: Number of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab

Time frame:From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Gantenerumab: DBTn=501 Participants	12	-

Publications (5)

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.