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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00884507

Run by

Hoffmann-La Roche

People needed

389

Starts

2009-05-01

Expected to finish

2010-11-01

Last updated by the study team

2016-11-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Torrance, California, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Delray Beach, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Paducah, Kentucky, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Creve Coeur, Missouri, United States
• Study site — Eatontown, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — White Plains, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Caba, Argentina
• Study site — Hornsby, New South Wales, Australia
• Study site — Chermside, Queensland, Australia
• Study site — Woodville, South Australia, Australia
• Study site — Medicine Hat, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Kingston, Ontario, Canada
• Study site — Orange, California, United States

Full record on ClinicalTrials.gov

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