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Trial record 85 of 331 for:    DONEPEZIL

Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Factors That Affect Aricept Medication Persistence Rate and the Safety and Efficacy in Patients With Alzheimer's Disease in Clinical Practice

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ClinicalTrials.gov Identifier: NCT02162264
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
To investigate the factors that affect Aricept medication persistence rate and the safety and efficacy in patients with Alzheimer's Disease in clinical practice

Condition or disease Intervention/treatment
Alzheimer's Disease Drug: Donepezil Hydrochloride

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Study Type : Observational
Actual Enrollment : 8662 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : June 1, 2013
Actual Primary Completion Date : May 30, 2015
Actual Study Completion Date : July 22, 2016


Group/Cohort Intervention/treatment
E2020 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.
Other Name: Aricept




Primary Outcome Measures :
  1. Change From Baseline in the Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline, Month 3, Month 6, and Month 12 ]

Secondary Outcome Measures :
  1. Investigations on adverse events and adverse drug reactions [ Time Frame: Baseline and Month 12 ]


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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 diagnosed with Alzheimer's Disease
Criteria

Inclusion criteria:

Patients diagnosed with Alzheimer's Disease and administered Aricept for the first time.

Exclusion criteria:

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 ClinicalTrials.gov identifier (NCT number): NCT02162264


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Kazuhiro Omata Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Publications of Results:
Geriatric Medicine 55(10): 1131-1145, 2017.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02162264     History of Changes
Other Study ID Numbers: ART08T
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: January 2017
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Alzheimer's Disease
donepezil hydrochloride
Additional relevant MeSH terms:
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Donepezil
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
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