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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

676 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2004-01-31

Brief Summary

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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

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Conditions

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Memory Disorders

Keywords

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Piracetam Nootropil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Piracetam

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

References

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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.

Reference Type RESULT

PMID: 16306154 (View on PubMed)

Other Identifiers

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N01001

Identifier Type: -

Identifier Source: org_study_id