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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00096473

Enrollment

229

Registered

2004-11-10

Start date

2001-01-31

Completion date

2005-09-30

Last updated

2011-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Dementia

Keywords

Alzheimer's Disease, dementia, acetylcholinesterase, donepezil, Aricept, memory loss, Severe dementia of the Alzheimer's type

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.

Interventions

DRUGDonepezil hydrochloride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assessments of global and cognitive function of Severe AD patients	—

Secondary

Measure	Time frame
Assessment of behavior and performance on Activity of Daily Living in severe AD patients	—
Assessment of caregiver burden	—

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026