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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00567060

Purpose

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.

Condition	Intervention
Memory Disorders	Drug: Piracetam

MedlinePlus related topics: Memory

Drug Information available for: Piracetam

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by UCB:

Primary Outcome Measures:

Secondary Outcome Measures:

Enrollment:	676
Study Start Date:	May 2000
Study 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567060

Sponsors and Collaborators

UCB

Investigators

Study Director:

Michel Daubresse

UCB

More Information

Publications of Results:

Study ID Numbers:	N01001
Study First Received:	November 30, 2007
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00567060
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by UCB:

Piracetam
Nootropil

Study placed in the following topic categories:

Signs and Symptoms
Piracetam
Neurologic Manifestations
Neurobehavioral Manifestations
Memory Disorders

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Central Nervous System Agents
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009