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OpenTrials
Completed

NCT Number: NCT00293176

The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)

To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.

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Key information

Conditions

Memory Loss Cognition Disorders Cognitive Dysfunction Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Albaster, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Memory complaint
  • Mini Mental Status Exam (MMSE) score 24-28 inclusive
  • General cognition and function performance sufficiently preserved such that a diagnosis of Alzheimer's disease (AD) cannot be made
  • Generally healthy and ambulatory
  • Sufficiently fluent in English

Exclusion criteria

  • Diagnosis of probable or possible AD
  • Neurological disorders
  • History of malignant cancers
  • Previously have taken donepezil or other acetylcholinesterase (ChE) inhibitors for more than 1 month or in the past 3 months prior to study entry

Treatment and study plan

Donepezil Hydrochloride

Drug

Subects will receive a starting dose of 5 mg orally. Dose-escalation from 5 mg to 10 mg will occur at the Week 9 Visit.

Placebo

Drug

Subjects will receive matching placebo tablets.

Primary outcomes

  1. Assessment of cognitive and global function in subjects with MCI.

Secondary outcomes

  1. Behavioral, global and cognitive outcomes; Neuroimaging

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Feb 17, 2006
Registry last updated
Apr 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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