A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 8/3/2016 |
| Start Date: | May 2009 |
| End Date: | November 2010 |
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
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.
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.
We found this trial at
15
sites
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