A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of 9600 and 4800 mg/Day Piracetam Taken for 12 Months by Subjects Suffering From Mild Cognitive Impairment (MCI)

UCB Pharma0 sites676 target enrollmentMay 2000

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2000

End Date

January 2004

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•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

•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