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