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

Roche

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: RO5313534

Study type: Interventional

Funder types: Industry

Identifiers

NCT00884507

WN22018

2008-004012-13

Details and patient eligibility

About

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.

Enrollment: 389 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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.

Trial design

389 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

RO5313534 15mg

Experimental group

Treatment:

Drug: RO5313534

Drug: RO5313534

Drug: RO5313534

RO5313534 1mg

Experimental group

Treatment:

Drug: RO5313534

Drug: RO5313534

Drug: RO5313534

RO5313534 5mg

Experimental group

Treatment:

Drug: RO5313534

Drug: RO5313534

Drug: RO5313534