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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.
 
ClinicalTrials.gov Identifier: NCT02162251
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. )

Tracking Information
First Submitted Date June 10, 2014
First Posted Date June 12, 2014
Last Update Posted Date September 7, 2018
Actual Study Start Date June 1, 2013
Actual Primary Completion Date May 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2014)
Investigations on adverse events and adverse drug reactions [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 5, 2015)
  • 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
  • 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.
Original Secondary Outcome Measures
 (submitted: June 11, 2014)
  • 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
  • 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 or 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Alzheimer's Disease
Condition Alzheimer's Desease
Intervention 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
Study Groups/Cohorts E2020
Intervention: Drug: Donepezil Hydrochloride
Publications *
  • Geriatric Medicine 55(1): 87-100, 2017.
  • Geriatric Medicine 55(11): 1251-1264, 2017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 30, 2016)
3482
Original Estimated Enrollment
 (submitted: June 11, 2014)
5000
Actual Study Completion Date April 15, 2016
Actual Primary Completion Date May 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02162251
Other Study ID Numbers ART07T
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eisai Inc. ( Eisai Co., Ltd. )
Study Sponsor Eisai Co., Ltd.
Collaborators Not Provided
Investigators Not Provided
PRS Account Eisai Inc.
Verification Date December 2016