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

Memory Disorders Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567060
• Other study ID #: N01001
• Status: Completed
• Phase: N/A
• First received: November 30, 2007
• Last updated: December 13, 2013
• Start date: May 2000
• Est. completion date: January 2004

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Memory Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• Piracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & 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. Epub 2005 Nov 23. Review. Erratum in: J Neurol Neurosurg Psychiatry. 2006 Jul;77(7):892. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Battery Composite Score over a 52-week period
Secondary	safety of piracetam for 12 months

External Links

•   Clinical Study Summary on UCB.com