Working… Menu
Trial record 71 of 332 for:    DONEPEZIL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01251718
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : February 27, 2017
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease Intervention/treatment
Alzheimer's Disease Drug: donepezil hydrochloride

Layout table for study information
Study Type : Observational
Actual Enrollment : 894 participants
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
Actual Study Start Date : December 1, 2010
Actual Primary Completion Date : October 14, 2015
Actual Study Completion Date : February 18, 2016

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. ADAS-Jcog (test of cognitive function) [ Time Frame: 36 month (12 weeks and every 6 months) ]

Secondary Outcome Measures :
  1. Adverse events/adverse drug reactions [ Time Frame: 36 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01251718

  Show 106 Study Locations
Sponsors and Collaborators
Eisai Co., Ltd.
Layout table for investigator information
Study Director: Shoya Yamakawa Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Layout table for additonal information
Responsible Party: Eisai Co., Ltd. Identifier: NCT01251718     History of Changes
Other Study ID Numbers: ART06T
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: January 2017
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Donepezil hydrochloride
Alzheimer's Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents