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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00567060
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : December 16, 2013
Sponsor:
Information provided by:
UCB Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Memory Disorders Drug: Piracetam Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 676 participants
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)
Study Start Date : May 2000
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Cognitive Battery Composite Score over a 52-week period

Secondary Outcome Measures :
  1. safety of piracetam for 12 months

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567060


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00567060    
Other Study ID Numbers: N01001
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
Piracetam
Nootropil
Additional relevant MeSH terms:
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Memory Disorders
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Piracetam
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Nootropic Agents