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

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

Conditions

• Alzheimer’s Disease
• Dementia

Study Type

Interventional

Study Design

• Treatment
• Randomized
• Double-Blind
• Placebo Control
• Parallel Assignment
• Safety/Efficacy Study

Further Details

Primary Outcomes:

Assessments of global and cognitive function of Severe AD patients.

Secondary Outcomes:

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

Assessment of caregiver burden Last follow-up: June 2005

Data entry closure: July 2005

Study Start

Study start: January 2001; Expected completion: September 2005

Eligibility & Criteria

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

Conditions

• Alzheimer’s Disease
• Dementia

Study Type

Interventional

Study Design

• Treatment
• Randomized
• Double-Blind
• Placebo Control
• Parallel Assignment
• Safety/Efficacy Study

Further Details

Primary Outcomes:

Assessments of global and cognitive function of Severe AD patients.

Secondary Outcomes:

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

Assessment of caregiver burden Last follow-up: June 2005

Data entry closure: July 2005

Study Start

Study start: January 2001; Expected completion: September 2005

Eligibility & Criteria

Ages Eligible for Study:

50 Years and above

Genders Eligible for Study: Both

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

Total Enrolment

350

Contact Details

[1] Eisai Medical Research Inc [2] Pfizer

Total Enrolment

350

Contact Details

[1] Eisai Medical Research Inc [2] Pfizer