Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)
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ClinicalTrials.gov Identifier: NCT00567060 |
Recruitment Status :
Completed
First Posted : December 4, 2007
Last Update Posted : December 16, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Memory Disorders | Drug: Piracetam | Not Applicable |
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 |
- Cognitive Battery Composite Score over a 52-week period
- safety of piracetam for 12 months

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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 |
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.

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
Study Director: | UCB Clinical Trial Call Center | UCB Pharma |
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 |
Piracetam Nootropil |
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 |