Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer’s Disease - Full Text View

Sponsor:	Eisai Inc.
Collaborator:	Pfizer
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00096473

Purpose

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 Dementia	Drug: Donepezil hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Memory

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

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

Estimated Enrollment:	350
Study Start Date:	January 2001
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096473

Show 41 Study Locations

Sponsors and Collaborators

Eisai Inc.

Pfizer

Investigators

Study Director:	Sharon Richardson, Ph.D.	Eisai Inc.
Study Director:	Honglan Li, Ph.D.	Eisai Inc.

More Information

No publications provided

Study ID Numbers:	E2020-A001-315
Study First Received:	November 9, 2004
Last Updated:	March 1, 2007
ClinicalTrials.gov Identifier:	NCT00096473 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Inc.:

Alzheimer's Disease
dementia
acetylcholinesterase
donepezil

Aricept
memory loss
Severe dementia of the Alzheimer's type

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases

Neurodegenerative Diseases
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Donepezil
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009