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Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride 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: NCT02162251
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : September 7, 2018
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice.

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

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Study Type : Observational
Actual Enrollment : 3482 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : June 1, 2013
Actual Primary Completion Date : May 1, 2015
Actual Study Completion Date : April 15, 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. Investigations on adverse events and adverse drug reactions [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Severity of dementia based on the Functional Assessment Staging Test (FAST) [ Time Frame: Baseline, Month 3, Month 6, and Month 12 ]
    FAST is a seven stage system based on level of functioning and daily activities. It focuses more on an individual's level of functioning and activities of daily living versus cognitive decline

  2. Change From Baseline in the Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline and Month 12 ]
    The MMSE is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.

Information from the National Library of Medicine

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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 with Alzheimer's Disease

Inclusion criteria:

Patients diagnosed with Alzheimer's Disease who are to be administered both donepezil hydrochloride and memantine hydrochloride in clinical practice.

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 identifier (NCT number): NCT02162251

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Multiple Locations, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Publications of Results:
Geriatric Medicine 55(1): 87-100, 2017.
Geriatric Medicine 55(11): 1251-1264, 2017.

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Responsible Party: Eisai Co., Ltd. Identifier: NCT02162251    
Other Study ID Numbers: ART07T
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: December 2016
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Alzheimer's Disease
donepezil hydrochloride
Additional relevant MeSH terms:
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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