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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00567060
First received: November 30, 2007
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Cognitive Battery Composite Score over a 52-week period

Secondary Outcome Measures:
  • safety of piracetam for 12 months

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

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00567060     History of Changes
Other Study ID Numbers: N01001
Study First Received: November 30, 2007
Last Updated: September 14, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by UCB, Inc.:
Piracetam
Nootropil

Additional relevant MeSH terms:
Memory Disorders
Cognition Disorders
Stress, Psychological
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
 Behavioral Symptoms
Piracetam
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Nootropic Agents

ClinicalTrials.gov processed this record on May 19, 2013