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

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Piracetam

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.