Status:
COMPLETED
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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, pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT00884507
Start Date
May 1 2009
End Date
November 1 2010
Last Update
November 2 2016
Active Locations (67)
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1
Orange, California, United States, 92868
2
Torrance, California, United States, 90502
3
Norwalk, Connecticut, United States, 06851
4
Delray Beach, Florida, United States, 33445