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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.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01251718
First received: December 1, 2010
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

To investigate the clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease


Condition Intervention Phase
Alzheimer's Disease
 Drug: donepezil hydrochloride
 Phase 4

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:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitals and Clinics in Japan

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251718

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

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01251718     History of Changes
Other Study ID Numbers: ART06T
Study First Received: December 1, 2010
Last Updated: October 11, 2012
Health Authority: Japan: Health, Labour and Welfare Ministry

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013