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
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