Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)
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)
1 other identifier
interventional
676
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2000
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 30, 2007
CompletedFirst Posted
Study publicly available on registry
December 4, 2007
CompletedDecember 16, 2013
September 1, 2009
3.7 years
November 30, 2007
December 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive Battery Composite Score over a 52-week period
Secondary Outcomes (1)
safety of piracetam for 12 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Related Publications (1)
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.
PMID: 16306154RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 30, 2007
First Posted
December 4, 2007
Study Start
May 1, 2000
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
December 16, 2013
Record last verified: 2009-09