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

Primary Purpose

Memory Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Piracetam
Sponsored by
UCB Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Disorders focused on measuring Piracetam, Nootropil

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Cognitive Battery Composite Score over a 52-week period

    Secondary Outcome Measures

    safety of piracetam for 12 months

    Full Information

    First Posted
    November 30, 2007
    Last Updated
    December 13, 2013
    Sponsor
    UCB Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00567060
    Brief Title
    Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2000 (undefined)
    Primary Completion Date
    January 2004 (Actual)
    Study Completion Date
    January 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    UCB Pharma

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Memory Disorders
    Keywords
    Piracetam, Nootropil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    676 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Piracetam
    Primary Outcome Measure Information:
    Title
    Cognitive Battery Composite Score over a 52-week period
    Secondary Outcome Measure Information:
    Title
    safety of piracetam for 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    UCB Clinical Trial Call Center
    Organizational Affiliation
    UCB Pharma
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16306154
    Citation
    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. doi: 10.1136/jnnp.2005.072926. Epub 2005 Nov 23. Erratum In: J Neurol Neurosurg Psychiatry. 2006 Jul;77(7):892.
    Results Reference
    result

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

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