← Trials/Trial dossier/NCT02051608

CompletedPhase 3Results posted

A Study of Gantenerumab in Participants With Mild Alzheimer Disease

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients

Lead sponsor

Hoffmann-La Roche

Asset

Gantenerumab

Listed sites

131

Recruiting sites

Enrollment

389

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Amyloid biomarker required (CSF)

Primary endpoint

•Part 2

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 number2013-003390-95

NCT IDNCT02051608

Org study IDWN28745

Timeline

Milestones

Study first posted2014-01-31estimated

Study start2014-03-27actual

Primary completion2021-04-16actual

Study completion2021-04-16actual

Results first posted2022-06-16actual

Last update posted2023-02-10actual

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

•Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved medication

•Cerebral spinal fluid (CSF) result consistent with the presence of amyloid pathology

•Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities

•Fluency in the language of the tests used at the study site

•Willingness and ability to complete all aspects of the study

•Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)

•If currently receiving approved medications for AD, the dosing regimen must have been stable for 3 months prior to screening

•Agreement not to participate in other research studies for the duration of this trial and its associated substudies

PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2

Exclusion criteria

•Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia

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

•History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months

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

•History of schizophrenia, schizoaffective disorder, or bipolar disorder

•Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years (nicotine use is allowed)

•History or presence of atrial fibrillation

•Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher)

•Uncontrolled hypertension

•Chronic kidney disease

•Impaired hepatic function

PET imaging substudy, in addition to above:

- Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits

Part 2 Participants who have been discontinued from the study

Endpoints (70)

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

Neuroimaging

Other (unclassified)

Safety / tolerability / PK

Global cognition

Caregiver / quality of life

Behavior / neuropsychiatric

Amyloid biomarkers

Tau biomarkers

Function / daily living

Global cognition

8 endpoints

Other/protocol endpoint

Part 1: Change From Baseline in Clinical Dementia Rating Global Score (CDR-GS) at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other/protocol endpoint

Part 1: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Week 104

Time frame:Baseline, Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Other/protocol endpoint

Part 1: Change From Baseline in Clinical Composite Score (Prespecified Items From The ADAS-Cog, MMSE, and CDR) at Week 104

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Other/protocol endpoint

Part 1: Percentage of Participants With ADAS-Cog Response

Time frame:Baseline up to Week 152

ADAS-Cog

threshold achievement, improvement

Other_pre_specified/registry result

Part 1: Change From Baseline in Clinical Dementia Rating Global Score (CDR-GS) at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other_pre_specified/registry result

Part 1: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Week 104

Time frame:Baseline, Week 104

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Other_pre_specified/registry result

Part 1: Change From Baseline in Clinical Composite Score (Prespecified Items From The ADAS-Cog, MMSE, and CDR) at Week 104

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Other_pre_specified/registry result

Part 1: Percentage of Participants With ADAS-Cog Response

Time frame:Baseline up to Week 152

ADAS-Cog

threshold achievement, improvement

Function / daily living

2 endpoints

Other/protocol endpoint

Part 1: Mean Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Scores at Week 104

Time frame:Baseline, Week 104

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Other_pre_specified/registry result

Part 1: Mean Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Scores at Week 104

Time frame:Baseline, Week 104

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

4 endpoints

Other/protocol endpoint

Part 1: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 104

Time frame:Baseline, Week 104

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other/protocol endpoint

Part 1: Change From Baseline in NPI Domain Score at Week 104

Time frame:Baseline, Week 104

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other_pre_specified/registry result

Part 1: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 104

Time frame:Baseline, Week 104

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other_pre_specified/registry result

Part 1: Change From Baseline in NPI Domain Score at Week 104

Time frame:Baseline, Week 104

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Amyloid biomarkers

4 endpoints

Secondary/protocol endpoint

Part 2: Change From Baseline in Brain Amyloid Load at Week 156 in a Subset of Participants

Time frame:Baseline, Week 156

Amyloid PET Centiloid

change from baseline, improvement

Secondary/registry result

Part 2: Change From Baseline in Brain Amyloid Load at Week 156 in a Subset of Participants

Time frame:Baseline, Week 156

Amyloid PET Centiloid

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mgn=13 Participants	-81.01	47.08
Part 2 (OLE Treatment): Gantenerumab up to 1200 mgn=8 Participants	-84.93	28.38

Other/protocol endpoint

Part 1: Percentage Change From Baseline in Abeta 1-42 Levels in CSF at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Other_pre_specified/registry result

Part 1: Percentage Change From Baseline in Abeta 1-42 Levels in CSF at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Tau biomarkers

4 endpoints

Other/protocol endpoint

Part 1: Percentage Change From Baseline in Total Tau (T-tau) in CSF at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Other/protocol endpoint

Part 1: Percentage Change From Baseline in Phosphorylated Tau [P-tau] in CSF at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Other_pre_specified/registry result

Part 1: Percentage Change From Baseline in Total Tau (T-tau) in CSF at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Other_pre_specified/registry result

Part 1: Percentage Change From Baseline in Phosphorylated Tau [P-tau] in CSF at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Neuroimaging

16 endpoints

Secondary/protocol endpoint

Part 2: Percent Change From Baseline in Hippocampal Volume at Week 104

Time frame:Baseline (Part 1 screening), Week 104

percent change from baseline, improvement

Secondary/protocol endpoint

Part 2: Percent Change From Baseline in Whole Brain Volume at Week 104

Time frame:Baseline (Part 1 screening), Week 104

percent change from baseline, improvement

Secondary/protocol endpoint

Part 2: Percent Change From Baseline in Cortical Thickness at Week 104

Time frame:Baseline (Part 1 screening), Week 104

percent change from baseline, improvement

Secondary/protocol endpoint

Part 2: Ventricular Volume as Measured by MRI at Week 104

Time frame:Part 2: Week 104

descriptive

Secondary/registry result

Part 2: Percent Change From Baseline in Hippocampal Volume at Week 104

Time frame:Baseline (Part 1 screening), Week 104

percent change from baseline, improvement

Posted result

Group	Value (mean), Percent Change	Standard deviation
Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mgHippocampal Left Volume- Percent Change at Week 104n=50 Participants	-11.24	4.04
Hippocampal Right Volume- Percent Change at Week 104n=52 Participants	-12.49	4.03
Part 2 (OLE Treatment): Gantenerumab up to 1200 mgHippocampal Left Volume- Percent Change at Week 104n=43 Participants	-12.10	4.45
Hippocampal Right Volume- Percent Change at Week 104n=44 Participants	-11.34	4.41

Secondary/registry result

Part 2: Percent Change From Baseline in Whole Brain Volume at Week 104

Time frame:Baseline (Part 1 screening), Week 104

percent change from baseline, improvement

Posted result

Group	Value (mean), Percent Change	Standard deviation
Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mgn=54 Participants	-4.89	1.90
Part 2 (OLE Treatment): Gantenerumab up to 1200 mgn=44 Participants	-4.91	1.58

Secondary/registry result

Part 2: Percent Change From Baseline in Cortical Thickness at Week 104

Time frame:Baseline (Part 1 screening), Week 104

percent change from baseline, improvement

Posted result

Group	Value (mean), Percent Change	Standard deviation
Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mgn=54 Participants	-5.84	2.33
Part 2 (OLE Treatment): Gantenerumab up to 1200 mgn=44 Participants	-5.58	1.87

Secondary/registry result

Part 2: Ventricular Volume as Measured by MRI at Week 104

Time frame:Part 2: Week 104

descriptive

Posted result

Group	Value (mean), mL	Standard deviation
Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mgn=63 Participants	86.70	38.37
Part 2 (OLE Treatment): Gantenerumab up to 1200 mgn=52 Participants	86.21	30.49

Other/protocol endpoint

Part 1: Percent Change From Baseline in Hippocampal Volume at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Other/protocol endpoint

Part 1: Percent Change From Baseline in Whole Brain Volume at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Other/protocol endpoint

Part 1: Percent Change From Baseline in Cortical Thickness at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Other/protocol endpoint

Part 1: Ventricular Volume as Measured by MRI at Week 104

Time frame:Baseline, Week 104

descriptive

Other_pre_specified/registry result

Part 1: Percent Change From Baseline in Hippocampal Volume at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Other_pre_specified/registry result

Part 1: Percent Change From Baseline in Whole Brain Volume at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Other_pre_specified/registry result

Part 1: Percent Change From Baseline in Cortical Thickness at Week 104

Time frame:Baseline, Week 104

percent change from baseline, improvement

Other_pre_specified/registry result

Part 1: Ventricular Volume as Measured by MRI at Week 104

Time frame:Baseline, Week 104

descriptive

Caregiver / quality of life

6 endpoints

Other/protocol endpoint

Part 1: Change From Baseline in Alzheimer's Dementia (QoL-AD) Global Score at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other/protocol endpoint

Part 1: Change From Baseline in Resource Utilization Dementia-Lite (RUD - Lite) Scale at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other/protocol endpoint

Part 1: Change From Baseline in Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other_pre_specified/registry result

Part 1: Change From Baseline in Alzheimer's Dementia (QoL-AD) Global Score at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other_pre_specified/registry result

Part 1: Change From Baseline in Resource Utilization Dementia-Lite (RUD - Lite) Scale at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other_pre_specified/registry result

Part 1: Change From Baseline in Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

Part 2: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame:First dose up to 4 weeks after the last dose of study drug (up to 249 weeks)

threshold achievement, event

Primary/protocol endpoint

Part 2: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment

Time frame:First dose up to 4 weeks after the last dose in OLE (Up to approximately 249 weeks)

threshold achievement, event

Primary/registry result

Part 2: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame:First dose up to 4 weeks after the last dose of study drug (up to 249 weeks)

threshold achievement, event

Posted result

Group	Value (number), Percentage of Participants	Reported bounds
Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mgAEsn=117 Participants	91.5	-
SAEsn=117 Participants	24.8	-
Part 2 (OLE Treatment): Gantenerumab up to 1200 mgAEsn=108 Participants	95.4	-
SAEsn=108 Participants	38.0	-

Primary/registry result

Part 2: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment

Time frame:First dose up to 4 weeks after the last dose in OLE (Up to approximately 249 weeks)

threshold achievement, event

Posted result

Group	Value (number), Percentage of Participants	Reported bounds
Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mgn=117 Participants	12.0	-
Part 2 (OLE Treatment): Gantenerumab up to 1200 mgn=108 Participants	15.7	-

Secondary/protocol endpoint

Part 1: Percentage of Participants With AEs, SAEs

Time frame:First dose up to last dose (Up to approximately 152 weeks)

threshold achievement, event

Secondary/protocol endpoint

Part 1: Gantenerumab Plasma Concentration at Multiple Timepoints

Time frame:Pre-dose: Weeks 4, 8, 12, 24, 48, 72 and Post dose: Day 4

concentration, descriptive

Secondary/protocol endpoint

Part 1: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment

Time frame:First dose up to last dose (Up to approximately 152 weeks)

threshold achievement, event

Secondary/protocol endpoint

Part 2: Gantenerumab Plasma Concentration at Multiple Timepoints

Time frame:Pre-dose: Weeks 104, 116, 156, 208; Post-dose: Weeks 53, 101

concentration, descriptive

Secondary/registry result

Part 1: Percentage of Participants With AEs, SAEs

Time frame:First dose up to last dose (Up to approximately 152 weeks)

threshold achievement, event

Posted result

Group	Value (number), Percentage of Participants	Reported bounds
Part 1: PlaceboAEsn=195 Participants	80.5	-
SAEsn=195 Participants	12.3	-
Part 1: GantenerumabAEsn=192 Participants	82.8	-
SAEsn=192 Participants	12.0	-

Secondary/registry result

Part 1: Gantenerumab Plasma Concentration at Multiple Timepoints

Time frame:Pre-dose: Weeks 4, 8, 12, 24, 48, 72 and Post dose: Day 4

concentration, descriptive

Posted result

Group	Value (mean), μg/mL	Standard deviation
GantenerumabDay 4n=183 Participants	4.11	2.59
Week 4n=190 Participants	2.06	0.89
Week 8n=188 Participants	3.11	1.41
Week 12n=184 Participants	3.35	1.63
Week 24n=177 Participants	3.71	2.13
Week 48n=137 Participants	7.61	3.88
Week 72n=79 Participants	7.66	4.44

Secondary/registry result

Part 1: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment

Time frame:First dose up to last dose (Up to approximately 152 weeks)

threshold achievement, event

Posted result

Group	Value (number), Percentage of Participants	Reported bounds
Part 1: Placebon=195 Participants	2.6	-
Part 1: Gantenerumabn=192 Participants	6.8	-

Secondary/registry result

Part 2: Gantenerumab Plasma Concentration at Multiple Timepoints

Time frame:Pre-dose: Weeks 104, 116, 156, 208; Post-dose: Weeks 53, 101

concentration, descriptive

Posted result

Group	Value (mean), μg/mL	Standard deviation
Part 2 (OLE Treatment): Gantenerumab 1200 mgWeek 53n=128 Participants	80.6	38.4
Week 101n=111 Participants	89.1	33.6
Week 104n=141 Participants	43.5	22.4
Week 116n=15 Participants	3.66	2.29
Week 156n=80 Participants	45.2	22.5
Week 208n=48 Participants	55.8	37.9

Other (unclassified)

14 endpoints

Primary/protocol endpoint/low confidence

Part 2: Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs)

Time frame:First dose up to last dose (Baseline up to until maximum 5 years)

threshold achievement, improvement

Primary/registry result/low confidence

Part 2: Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs)

Time frame:First dose up to last dose (Baseline up to until maximum 5 years)

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of Participants	Reported bounds
Part 2 (OLE Treatment): Placebo Switched to Gantenerumab up to 1200 mgn=115 Participants	2.6	-
Part 2 (OLE Treatment): Gantenerumab up to 1200 mgn=106 Participants	2.8	-

Secondary/protocol endpoint/low confidence

Part 1: Percentage of Participants With Treatment Emergent ADAs

Time frame:First dose up to last dose (Up to approximately 152 weeks)

threshold achievement, improvement

Secondary/registry result/low confidence

Part 1: Percentage of Participants With Treatment Emergent ADAs

Time frame:First dose up to last dose (Up to approximately 152 weeks)

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of Participants	Reported bounds
Part 1: Placebon=194 Participants	3.6	-
Part 1: Gantenerumabn=191 Participants	11.5	-

Other/protocol endpoint/low confidence

Part 1: Mean Change From Baseline in Alzheimer's Disease Activity Scale-Cognitive Subscale 13 (ADAS-Cog13) Scores at Week 104

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Other/protocol endpoint/low confidence

Part 1: Change From Baseline in CDR Sum of Boxes (SB) at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other/protocol endpoint/low confidence

Part 1: Change From Baseline in Symptom Guide Facilitated (GAS) at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other/protocol endpoint/low confidence

Part 1: Change From Baseline in Dependence Scale (DS) at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other/protocol endpoint/low confidence

Part 1: Time to Clinical Decline

Time frame:Baseline up to Week 104

time to event, event

Other_pre_specified/registry result/low confidence

Part 1: Mean Change From Baseline in Alzheimer's Disease Activity Scale-Cognitive Subscale 13 (ADAS-Cog13) Scores at Week 104

Time frame:Baseline, Week 104

ADAS-Cog

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Part 1: Change From Baseline in CDR Sum of Boxes (SB) at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Part 1: Change From Baseline in Symptom Guide Facilitated (GAS) at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Part 1: Change From Baseline in Dependence Scale (DS) at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Part 1: Time to Clinical Decline

Time frame:Baseline up to Week 104

time to event, event

Publications (2)

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.