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

Not Applicable

Completed

• Conditions: Memory Disorders

• Registration Number: NCT00567060
• Lead Sponsor: UCB Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-04
• Status Verified: 2009-09
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 676

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive Battery Composite Score over a 52-week period

Secondary Outcome Measures

Name	Time	Method
safety of piracetam for 12 months