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

UCB

Status: Completed

Conditions: Memory Disorders

Treatments: Drug: Piracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567060

N01001

Details and patient eligibility

About

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.

Enrollment: 676 patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind