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

• ClinicalTrials.gov Identifier: NCT00567060
• Recruitment Status: Completed
• First Posted: December 4, 2007
• Last Update Posted: December 16, 2013
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

Tracking Information

• First Submitted Date: November 30, 2007
• First Posted Date: December 4, 2007
• Last Update Posted Date: December 16, 2013
• Study Start Date: May 2000
• Actual Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 30, 2007): Cognitive Battery Composite Score over a 52-week period
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 30, 2007): safety of piracetam for 12 months
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Memory Disorders
• Intervention: Drug: Piracetam
• Study Arms: Not Provided
• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 30, 2007): 676
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2004
• Actual Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00567060
• Other Study ID Numbers: N01001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: UCB Pharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: UCB Clinical Trial Call Center; UCB Pharma

• PRS Account: UCB Pharma
• Verification Date: September 2009