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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00884507

Enrollment

389

Registered

2009-04-20

Start date

2009-05-31

Completion date

2010-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.

Interventions

DRUGPlacebo

po daily for 24 weeks

DRUGRO5313534

1mg po daily for 24 weeks

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score	Week 24

Secondary

Measure	Time frame
CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview	At intervals up to week 24, then at week 28
AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.	At intervals to week 24, then at week 28

Countries

Argentina, Australia, Canada, France, Germany, Italy, Mexico, Poland, Romania, Slovakia, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026