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

Condition(s) targeted: Alzheimer's Disease; Dementia

Intervention: Donepezil hydrochloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Sharon Richardson, Ph.D., Study Director, Affiliation: Eisai Inc.
Honglan Li, Ph.D., Study Director, Affiliation: Eisai Inc.

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Assessments of global and cognitive function of Severe AD patients

Secondary outcome:

Assessment of behavior and performance on Activity of Daily Living in severe AD patients

Assessment of caregiver burden

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

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Starting date: January 2001
Ending date: June 2005
Last updated: March 1, 2007