Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. ) Identifier:
First received: December 1, 2010
Last updated: April 20, 2015
Last verified: April 2015
To investigate the clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease

Condition Intervention
Alzheimer's Disease
Drug: donepezil hydrochloride

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Surveillance of Donepezil Hydrochloride- Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • ADAS-Jcog (test of cognitive function) [ Time Frame: 36 month (12 weeks and every 6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events/adverse drug reactions [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: October 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Donepezil Hydrochloride Drug: donepezil hydrochloride
Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Alzheimer's Disease

Inclusion criteria;

Patients diagnosed as Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).

Patients diagnosed as mild or moderate Alzheimer's Disease, applicable to Functional Assessment Staging (FAST) score 4 or 5.

Exclusion criteria;

Patients who used Aricept within 3 months prior to dosing.

Patients registered this survey before.

Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01251718

  Show 106 Study Locations
Sponsors and Collaborators
Eisai Co., Ltd.
Study Director: Shoya Yamakawa Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
  More Information

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. ) Identifier: NCT01251718     History of Changes
Other Study ID Numbers: ART06T 
Study First Received: December 1, 2010
Last Updated: April 20, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Donepezil hydrochloride
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Physiological Effects of Drugs processed this record on May 26, 2016