Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)

Launched by UCB PHARMA · Nov 30, 2007

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.