The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
229
evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil.
10 mg donepezil QD dosed up to 40 weeks
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
Time frame: weeks 12, 14, 26 and 40.
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.
Time frame: weeks 12, 14, 26 and 40.
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Costa Mesa, California, United States
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Fresno, California, United States
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La Jolla, California, United States
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Orange, California, United States
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Boca Raton, Florida, United States
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Delray Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
...and 46 more locations