TerminatedPhase 2Results posted

A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

A Phase II, Multicenter, Open-Label, Single Arm Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early (Prodromal to Mild) Alzheimer's Disease

Lead sponsor

Hoffmann-La Roche

Asset

Gantenerumab

Listed sites

Recruiting sites

Enrollment

192

actual

Study population

Alzheimer’s disease

Key I/E criteria

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

Primary endpoint

•Amyloid PET Centiloid

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

Registry2020-001384-87EudraCT

NCT IDNCT04592341

Org study IDWN29722

Timeline

Milestones

Study first posted2020-10-19actual

Study start2020-11-18actual

Primary completion2023-01-11actual

Study completion2023-03-15actual

Last update posted2024-03-27actual

Results first posted2024-03-27actual

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

•Probable Alzheimer's Disease (AD) dementia or prodromal AD.

•Availability of a reliable study partner (non-professional caregiver) who accepts to participate in study procedure throughout the study duration

•The participant should be capable of completing all aspects of study assessments including MRI, clinical genotyping, and PET imaging, either alone or with the help of the study partner (non-professional caregiver).

•Adequate visual and auditory acuitysufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted).

•Evidence of AD pathological process, as confirmed by amyloid PET scan by qualitative read by the core/central PET laboratory.

•Prodromal or mild symptomatology, as defined by a screening Mini-Mental State Examination (MMSE) score >/=22 and Clinical Dementia Rating global score (CDR-GS) of 0.5 or 1.0, as well as a clinical dementia rating (CDR) memory domain score >/=0.5.

•If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 3 months prior to screening and until start of study treatment.

•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.

•Agreement not to participate in other research studies for the duration of this trial, unless these are related Roche-sponsored non-interventional studies.

•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods hat result in a failure rate of < 1% per year during the treatment period and for at least 16 weeks after the final dose of study drug

Exclusion criteria

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

•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 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.

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

•At risk for suicide in the opinion of the investigator.

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

Endpoints (20)

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

Safety / tolerability / PK

Other (unclassified)

Behavior / neuropsychiatric

Caregiver / quality of life

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

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

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Secondary/registry result

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

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
GantenerumabSuicidal Ideation: Passiven=191 Participants	6	-
Suicidal Ideation: Active-Nonspecificn=191 Participants	1	-
Suicidal Ideation: Active-Method, But No Intent or Plann=191 Participants	3	-
Suicidal Ideation: Active-Method, Intent, and Plann=191 Participants	1	-
Suicidal Ideation: No Eventn=191 Participants	180	-
Suicidal Behavior: No Eventn=191 Participants	191	-
Self-Injurious Behavior w/o suicidal intent: No Eventn=191 Participants	191	-

Amyloid biomarkers

8 endpoints

Primary/protocol endpoint

Change From Baseline in Brain Amyloid Load at Week 104 as Measured by [18F] Florbetaben Positron Emission Tomography (PET) Scan

Time frame:Baseline, Week 104

Amyloid PET Centiloid

change from baseline, improvement

Primary/registry result

Change From Baseline in Brain Amyloid Load at Week 104 as Measured by [18F] Florbetaben Positron Emission Tomography (PET) Scan

Time frame:Baseline, Week 104

Amyloid PET Centiloid

change from baseline, improvement

Posted result

Group	Value (mean), centiloid	Standard deviation
GantenerumabBaselinen=192 Participants	101.80	29.80
Change from Baseline at Week 104n=12 Participants	-35.48	16.39

Secondary/protocol endpoint

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

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Secondary/protocol endpoint

Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI)

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Secondary/registry result

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

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Gantenerumabn=192 Participants	44	-

Secondary/registry result

Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI)

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Gantenerumabn=192 Participants	44	-

Secondary/protocol endpoint

Change in Brain Amyloid Based on Different Dosing Frequency

Time frame:Baseline up to Week 52

Amyloid PET Centiloid

change from baseline, improvement

Secondary/registry result

Change in Brain Amyloid Based on Different Dosing Frequency

Time frame:Baseline up to Week 52

Amyloid PET Centiloid

change from baseline, improvement

Posted result

Group	Value (mean), centiloid	Standard deviation
Gantenerumabn=149 Participants	-26.19	17.60

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)

Time frame:Weeks 36, 52, 76, 104

event count, event

Secondary/registry result

Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)

Time frame:Weeks 36, 52, 76, 104

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
GantenerumabW36:Q1:Not at all confidentn=72 Participants	0	-
W36:Q1:Somewhat confidentn=72 Participants	10	-
W36:Q1:Confidentn=72 Participants	33	-
W36:Q1:Very confidentn=72 Participants	29	-
W52:Q1:Not at all confidentn=148 Participants	0	-
W52:Q1:Somewhat confidentn=148 Participants	10	-
W52:Q1:Confidentn=148 Participants	46	-
W52:Q1:Very confidentn=148 Participants	92	-
W76:Q1:Not at all confidentn=126 Participants	1	-
W76:Q1:Somewhat confidentn=126 Participants	5	-
W76:Q1:Confidentn=126 Participants	34	-
W76:Q1:Very Confidentn=126 Participants	86	-
W104:Q1:Not at all confidentn=29 Participants	0	-
W104:Q1:Somewhat confidentn=29 Participants	2	-
W104:Q1:Confidentn=29 Participants	6	-
W104:Q1:Very Confidentn=29 Participants	21	-
W36:Q2:Not at all convenientn=72 Participants	1	-
W36:Q2:Somewhat convenientn=72 Participants	2	-
W36:Q2:Convenientn=72 Participants	13	-
W36:Q2:Very convenientn=72 Participants	56	-
W52:Q2:Not at all convenientn=148 Participants	0	-
W52:Q2:Somewhat convenientn=148 Participants	5	-
W52:Q2:Convenientn=148 Participants	38	-
W52:Q2:Very convenientn=148 Participants	105	-
W76:Q2:Not at all convenientn=126 Participants	0	-
W76:Q2:Somewhat convenientn=126 Participants	3	-
W76:Q2:Convenientn=126 Participants	23	-
W76:Q2:Very convenientn=126 Participants	100	-
W104:Q2:Not at all convenientn=29 Participants	0	-
W104:Q2:Somewhat convenientn=29 Participants	1	-
W104:Q2:Convenientn=29 Participants	5	-
W104:Q2:Very convenientn=29 Participants	23	-
W36:Q3:Not at all easyn=72 Participants	0	-
W36:Q3:Somewhat easyn=72 Participants	10	-
W36:Q3: Easyn=72 Participants	31	-
W36:Q3:Very easyn=72 Participants	31	-
W52:Q3:Not at all easyn=148 Participants	1	-
W52:Q3:Somewhat easyn=148 Participants	17	-
W52:Q3: Easyn=148 Participants	45	-
W52:Q3:Very easyn=148 Participants	85	-
W76:Q3:Not at all easyn=126 Participants	0	-
W76:Q3:Somewhat easyn=126 Participants	7	-
W76:Q3: Easyn=126 Participants	37	-
W76:Q3:Very easyn=126 Participants	82	-
W104:Q3:Not at all easyn=29 Participants	0	-
W104:Q3:Somewhat easyn=29 Participants	3	-
W104:Q3: Easyn=29 Participants	5	-
W104:Q3:Very easyn=29 Participants	21	-
W36:Q4:Not at all satisfiedn=72 Participants	0	-
W36:Q4:Somewhat satisfiedn=72 Participants	3	-
W36:Q4:Satisfiedn=72 Participants	26	-
W36:Q4:Very satisfiedn=72 Participants	43	-
W52:Q4:Not at all satisfiedn=148 Participants	0	-
W52:Q4:Somewhat satisfiedn=148 Participants	8	-
W52:Q4: Satisfiedn=148 Participants	44	-
W52:Q4:Very satisfiedn=148 Participants	96	-
W76:Q4:Not at all satisfiedn=126 Participants	0	-
W76:Q4:Somewhat satisfiedn=126 Participants	3	-
W76:Q4:Satisfiedn=126 Participants	38	-
W76:Q4:Very satisfiedn=126 Participants	85	-
W104:Q4:Not at all satisfiedn=29 Participants	0	-
W104:Q4:Somewhat satisfiedn=29 Participants	0	-
W104:Q4:Satisfiedn=29 Participants	8	-
W104:Q4:Very satisfiedn=29 Participants	21	-

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Secondary/registry result

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
GantenerumabAEsn=192 Participants	178	-
SAEsn=192 Participants	26	-

Secondary/protocol endpoint

Plasma Concentration of Subcutaneous (SC) Gantenerumab at Specified Timepoints

Time frame:Day 4 of Week 1, Week 24, 36, 52, and 76

concentration, descriptive

Secondary/registry result

Plasma Concentration of Subcutaneous (SC) Gantenerumab at Specified Timepoints

Time frame:Day 4 of Week 1, Week 24, 36, 52, and 76

concentration, descriptive

Posted result

Group	Value (geometric_mean), microgram per milliliter	Geometric coefficient of variation
GantenerumabDay 4 of Week 1n=190 Participants	5.24	73.3
Week 24n=166 Participants	11.9	52.0
Week 36n=147 Participants	28.8	50.2
Week 52n=129 Participants	71.4	49.0
Week 76n=84 Participants	63.6	50.8

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Number of Participants With Injection-Site Reactions (ISR)

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Treatment-emergent Anti-Drug Antibodies to Gantenerumab

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Secondary/registry result/low confidence

Number of Participants With Injection-Site Reactions (ISR)

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Gantenerumabn=192 Participants	44	-

Secondary/registry result/low confidence

Number of Participants With Treatment-emergent Anti-Drug Antibodies to Gantenerumab

Time frame:From day of first dose up to 16 weeks after the last dose (up to 120 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Gantenerumabn=191 Participants	26	-

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.