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

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Eisai

Status and phase

Completed
Phase 3

Conditions

Alzheimer's Disease
Dementia

Treatments

Drug: Donepezil hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00096473
E2020-A001-315

Details and patient eligibility

About

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.

Enrollment

229 patients

Sex

All

Ages

50+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

42

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Data sourced from clinicaltrials.gov

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