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
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|ClinicalTrials.gov Identifier: NCT02162251|
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment|
|Alzheimer's Desease||Drug: Donepezil Hydrochloride|
|Study Type :||Observational|
|Actual Enrollment :||3482 participants|
|Actual Study Start Date :||June 1, 2013|
|Actual Primary Completion Date :||May 1, 2015|
|Actual Study Completion Date :||April 15, 2016|
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
- Investigations on adverse events and adverse drug reactions [ Time Frame: Up to 12 months ]
- 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.
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): NCT02162251
|Multiple Locations, Japan|