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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

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

NCT ID

NCT00567060

First Posted

November 30, 2007

Last Updated

December 13, 2013

Sponsor

UCB Pharma

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

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

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

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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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