Overview
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
Status:
Completed
Completed
Trial end date:
2010-11-01
2010-11-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La RocheTreatments:
Donepezil
Criteria
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.