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Merck & Co Inc Initiates Phase II/III Study Of Investigational BACE Inhibitor, MK-8931, For Treatment Of Alzheimer's Disease


Monday, 3 Dec 2012 06:30am EST 

Merck & Co Inc announced it has started a Phase II/III clinical trial designed to evaluate the safety and efficacy of MK-8931 versus placebo in patients with mild-to-moderate Alzheimer's disease. MK-8931 is Merck's investigational oral β-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor, and is the first with this mechanism to advance to this stage of clinical research. The global, multi-center study, called EPOCH, is designed to initially evaluate the safety of MK-8931 in a cohort of 200 patients prior to advancing into a larger Phase III study. EPOCH is a 78-week, randomized, placebo-controlled, parallel-group, double-blind Phase II/III clinical trial to evaluate the efficacy and safety of one of three oral doses of MK-8931 (12, 40 or 60 mg) administered daily versus placebo. The study is anticipated to eventually enroll up to 1,700 patients in the main Phase III cohort. The primary efficacy outcomes of the study are the change from baseline in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and the change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score. The amyloid hypothesis asserts that the formation of amyloid peptides that lead to amyloid plaque deposits in the brain is the underlying cause of Alzheimer's disease. BACE is believed to be a key enzyme in the production of amyloid β peptide. 

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