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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00567060

Enrollment

676

Registered

2007-12-04

Start date

2000-05-31

Completion date

2004-01-31

Last updated

2013-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Memory Disorders

Keywords

Piracetam, Nootropil

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.

Interventions

DRUGPiracetam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to 89 Years

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.

Design outcomes

Primary

Measure	Time frame
Cognitive Battery Composite Score over a 52-week period	—

Secondary

Measure	Time frame
safety of piracetam for 12 months	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026