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