Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00096473
Recruitment Status : Completed
First Posted : November 10, 2004
Last Update Posted : April 1, 2011
Information provided by:
Eisai Inc.

Brief Summary:

Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.

Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Drug: Donepezil hydrochloride Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period
Study Start Date : January 2001
Actual Primary Completion Date : June 2005
Actual Study Completion Date : September 2005

Primary Outcome Measures :
  1. Assessments of global and cognitive function of Severe AD patients

Secondary Outcome Measures :
  1. Assessment of behavior and performance on Activity of Daily Living in severe AD patients
  2. Assessment of caregiver burden

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinically diagnosed Alzheimer's Disease with MMSE score 1~12
  • Have not been treated by any medication for Alzheimer's Disease in past 3 months
  • Live in community or Assisted Living Facility
  • Healthy or with chronic diseases that are medically controlled or stabilized
  • Able to swallow tablets

Exclusion Criteria:

  • Any primary neurological or psychiatric diagnosis (including depressive disorder) other than Alzheimer's Disease
  • Dementia caused by organic diseases other than Alzheimer's Disease

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 identifier (NCT number): NCT00096473

  Show 42 Study Locations
Sponsors and Collaborators
Eisai Inc.
Study Director: Sharon Richardson, Ph.D. Eisai Inc.
Study Director: Honglan Li, Ph.D. Eisai Inc. Identifier: NCT00096473     History of Changes
Other Study ID Numbers: E2020-A001-315
First Posted: November 10, 2004    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: March 2011

Keywords provided by Eisai Inc.:
Alzheimer's Disease
memory loss
Severe dementia of the Alzheimer's type

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents