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CompletedPhase 1

A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients

A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Gantenerumab Following Subcutaneous Injection in Japanese AD Patients

Asset

Gantenerumab

Listed sites

5

Recruiting sites

-

Enrollment

28

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-26

Primary endpoints

•Adverse Events•Pharmacokinetic parameters of Gantenerumab in plasma•CSF/plasma ratios of Gantenerumab

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

RegistryJapicCTI-121849JAPIC
Org study IDJP22431
NCT IDNCT01656525

Timeline

Milestones

Study start2012-06 (month precision)
Study first posted2012-08-03estimated
Primary completion2014-03actual (month precision)
Study completion2014-06actual (month precision)
Last update posted2014-09-19estimated

Assets

Drug assets

Gantenerumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have a diagnosis of probable AD dementia, based on NINCDS/ADRDA criteria
•Meet DSM-IV criteria for Dementia of the Alzheimer type
•MMSE score : 16 to 26 etc

Exclusion criteria

•Meet the exclusion criteria of MRI at screening.
•A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.

etc.

Endpoints (6)

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

Fluid / digital biomarkers
2
Safety / tolerability / PK
2
Global cognition
1
Amyloid biomarkers
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog).

Time frame:Baseline,Day85, 197, 253

ADAS-Cog

change from baseline, improvement

Amyloid biomarkers

1 endpoint
Secondary/protocol endpoint

Change from baseline in plasma Abeta

Time frame:Baseline,Day183

change from baseline, improvement

Fluid / digital biomarkers

2 endpoints
Primary/protocol endpoint

CSF/plasma ratios of Gantenerumab.

Time frame:Baseline, Day183

ratio, descriptive

Secondary/protocol endpoint

Change from baseline in plasma and CSF tau

Time frame:Baseline,Day183

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Number of participants with Adverse Events

Time frame:36 weeks

event count, event

Primary/protocol endpoint

Pharmacokinetic parameters of Gantenerumab in plasma

Time frame:36 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.