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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00293176
First received: February 16, 2006
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Memory Loss
Drug: Donepezil Hydrochloride
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

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

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

Enrollment: 821
Study Start Date: December 2003
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293176

  Show 54 Study Locations
Sponsors and Collaborators
Eisai Inc.
Pfizer
Investigators
Study Director: Anita Murthy Eisai Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00293176     History of Changes
Obsolete Identifiers: NCT00100022
Other Study ID Numbers: E2020-A001-412
Study First Received: February 16, 2006
Last Updated: March 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Cognitive impairment
Memory Loss

Additional relevant MeSH terms:
Amnesia
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Memory Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014