A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of 9600 and 4800 mg/Day Piracetam Taken for 12 Months by Subjects Suffering From Mild Cognitive Impairment (MCI)

UCB Pharma0 个研究点目标入组 676 人开始时间: 2000年5月最近更新: 2013年12月16日

适应症

试验速览

The purpose of this study was to explore in a more documented way the relative potential and efficacy of piracetam 9600 and 4800 mg daily.

•male/female between 50 and 89 years (inclusive)
•declining cognitive function of at least 3 months duration interfering with complex activities of daily living
•normal basic activities of daily independent living
•Clinical Dementia Rating scale score equal to 0.5
•score at least one point above the lowest possible score on 7 out of 8 tests in the cognitive battery at both Selection Visit and Baseline Visit

•general anesthetics within 3 months of selection visit
•history of severe allergic drug reaction(s)
•history of drug or alcohol dependence (DSM IV defined) within the last 12 months
•any drug prescribed to activate cerebral metabolism, taken within 1 week of screening or/and concomitantly
•concomitant intake of anticoagulent medications
•concomitant intake or intake within 1 week before screening of drug that might affect cognitive function or central nervous system
•history of dementia, psychiatric or neurological disorders, mental retardation, learning disabilities and stroke
•current depression
•impaired renal function, thyroid function or neurological degeneration
•any gastrointestinal dysfunction that might interfere with the absorption or elimination of the study drug
•insulin-dependant diabetes mellitus
•bleeding disorders or disturbance in hemostatic function.

Cognitive Battery Composite Score over a 52-week period

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