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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

Tracking Information
First Submitted Date  ICMJE November 30, 2007
First Posted Date  ICMJE December 4, 2007
Last Update Posted Date December 16, 2013
Study Start Date  ICMJE May 2000
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2007)		 Cognitive Battery Composite Score over a 52-week period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2007)		 safety of piracetam for 12 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Memory Disorders
Intervention  ICMJE Drug: Piracetam
Study Arms  ICMJE Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2007)		 676
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2004
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00567060
Other Study ID Numbers  ICMJE N01001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center UCB Pharma
PRS Account UCB Pharma
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP