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

This study has been completed.
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
First received: November 9, 2004
Last updated: March 31, 2011
Last verified: March 2011

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 Intervention Phase
Alzheimer's Disease
Drug: Donepezil hydrochloride
Phase 3

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 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

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

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

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

Enrollment: 229
Study Start Date: January 2001
Study Completion Date: September 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  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: 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.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00096473     History of Changes
Other Study ID Numbers: E2020-A001-315 
Study First Received: November 9, 2004
Last Updated: March 31, 2011
Health Authority: United States: Food and Drug Administration

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
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 February 07, 2016