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

Dementia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096473
• Other study ID #: E2020-A001-315
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2004
• Last updated: March 31, 2011
• Start date: January 2001
• Est. completion date: September 2005

Study information

• Verified date: March 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: September 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• Donepezil hydrochloride

Locations

Country	Name	City	State
France	Hôpital Broca-La Rochefoucauld	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessments of global and cognitive function of Severe AD patients
Secondary	Assessment of behavior and performance on Activity of Daily Living in severe AD patients
Secondary	Assessment of caregiver burden