CompletedPhase 2

A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease

A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease

Lead sponsor

Hoffmann-La Roche

Asset

RO5313534

Listed sites

Recruiting sites

Enrollment

389

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 13-22

Primary endpoint

•ADAS-Cog

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

Secondary2008-004012-13

NCT IDNCT00884507

Org study IDWN22018

Timeline

Milestones

Study first posted2009-04-20estimated

Study start2009-05 (month precision)

Primary completion2010-11actual (month precision)

Study completion2010-11actual (month precision)

Last update posted2016-11-02estimated

Assets

Drug assets

RO5313534

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•adult patients, >/=50 years of age;

•probable Alzheimer's disease;

•MMSE score at screening of 13-22;

•under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for >=4 months prior to baseline;

•not requiring nursing home care, but looked after by a caregiver/carer

Exclusion criteria

•dementia due to condition other than Alzheimer's disease;

•other significant neurological disorder;

•untreated/non-stabilized major depressive disorder;

•bipolar disorder, schizophrenia, or any other serious psychiatric condition.

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

Global cognition

Other (unclassified)

Global cognition

2 endpoints

Primary/protocol endpoint

Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score

Time frame:Week 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview

Time frame:At intervals up to week 24, then at week 28

Mini-Mental State Examination (MMSE)

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.

Time frame:At intervals to week 24, then at week 28

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.