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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
389
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Time frame: Week 24
CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview
Time frame: At intervals up to week 24, then at week 28
AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.
Time frame: At intervals to week 24, then at week 28
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15mg po daily for 24 weeks
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Orange, California, United States
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Torrance, California, United States
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Norwalk, Connecticut, United States
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Delray Beach, Florida, United States
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Fort Myers, Florida, United States
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Maitland, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Paducah, Kentucky, United States
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Kalamazoo, Michigan, United States
...and 57 more locations