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

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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.


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
1709
mi
from 98109
Creve Coeur, MO
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1184
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from 98109
Albuquerque, NM
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6918
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Buenos Aires,
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2693
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Delray Beach, FL
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2412
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Eatontown, NJ
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2615
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Ft Myers, FL
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1819
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Kalamazoo, MI
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2543
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Maitland, FL
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2416
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from 98109
Norwalk, CT
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984
mi
from 98109
Orange, CA
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1854
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from 98109
Paducah, KY
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147
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Portland, OR
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2527
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Tampa, FL
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975
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Torrance, CA
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2404
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from 98109
White Plains, NY
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