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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.
Information provided by:
UCB Pharma Identifier:
First received: November 30, 2007
Last updated: December 13, 2013
Last verified: September 2009
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
Intervention Model: Parallel Assignment
Masking: Double
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:

Further study details as provided by UCB Pharma:

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)

Ages Eligible for Study:   50 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00567060

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
Publications: Identifier: NCT00567060     History of Changes
Other Study ID Numbers: N01001
Study First Received: November 30, 2007
Last Updated: December 13, 2013

Keywords provided by UCB Pharma:

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Memory Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on September 21, 2017