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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 30, 2007

Last Updated Date

April 16, 2008

Start Date ^†

May 2000

Current Primary Outcome Measures ^†

Cognitive Battery Composite Score over a 52-week period

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00567060 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

safety of piracetam for 12 months

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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)

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

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Memory Disorders

Intervention ^†

Drug: Piracetam

Study Arms / Comparison Groups

Publications *

Jelic V, Kivipelto M, Winblad B. Clinical trials in mild cognitive impairment: lessons for the future. J Neurol Neurosurg Psychiatry. 2006 Apr;77(4):429-38. Epub 2005 Nov 23. Review. Erratum in: J Neurol Neurosurg Psychiatry. 2006 Jul;77(7):892.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

676

Completion Date

January 2004

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

50 Years to 89 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00567060

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

UCB

Collaborators ^††

Investigators ^†

Study Director:

Michel Daubresse

UCB

Information Provided By

UCB

Verification Date

April 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.