CompletedPhase 1

A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.

A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4909832 Following Intravenous Infusion in AD Patients

Lead sponsor

Hoffmann-La Roche

Asset

Gantenerumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•AEs, laboratory parameters, vital signs•Pharmacokinetic parameters of R1450 in plasma

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

NCT IDNCT00531804

Org study IDNN19866

Timeline

Milestones

Study start2006-12 (month precision)

Study first posted2007-09-19estimated

Primary completion2010-09actual (month precision)

Study completion2010-09actual (month precision)

Last update posted2016-11-02estimated

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

•adult patients, 50-90 years of age;

•diagnosis of probable Alzheimer Disease, with symptoms >=1 year prior to screening;

•meets DSM-IV criteria for Alzheimer-type dementia;

•stabilised on approved medications for treatment of Alzheimer Disease for >=4 months prior to baseline

Exclusion criteria

•active major depressive disorder, or a history of bipolar disorder;

•history of schizophrenia;

•concurrent participation in a non-pharmacological trial with a key objective of improving cognition;

•prior randomisation in any R1450 trial.

Endpoints (3)

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

Safety / tolerability / PK

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

CSF biomarkers, clinical efficacy parameters.

Time frame:Throughout study

descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

AEs, laboratory parameters, vital signs.

Time frame:Throughout study

descriptive

Primary/protocol endpoint

Pharmacokinetic parameters of R1450 in plasma

Time frame:Throughout study

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.