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

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ClinicalTrials.gov Identifier: NCT00293176
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : April 1, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eisai Inc.

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

Condition or disease Intervention/treatment Phase
Memory Loss Drug: Donepezil Hydrochloride Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 821 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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)
Study Start Date : December 2003
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Donepezil Hydrochloride
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 Comparator: 2 Drug: Placebo
Subjects will receive matching placebo tablets.



Primary Outcome Measures :
  1. Assessment of cognitive and global function in subjects with MCI.

Secondary Outcome Measures :
  1. Behavioral, global and cognitive outcomes; Neuroimaging


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293176


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Sponsors and Collaborators
Eisai Inc.
Pfizer
Investigators
Study Director: Anita Murthy Eisai Inc.

ClinicalTrials.gov Identifier: NCT00293176     History of Changes
Obsolete Identifiers: NCT00100022
Other Study ID Numbers: E2020-A001-412
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: March 2011

Keywords provided by Eisai Inc.:
Cognitive impairment
Memory Loss

Additional relevant MeSH terms:
Cognitive Dysfunction
Memory Disorders
Amnesia
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents