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
- Registration Number
- NCT02162251
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3482
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description E2020 Donepezil Hydrochloride -
- Primary Outcome Measures
Name Time Method Investigations on adverse events and adverse drug reactions Up to 12 months
- Secondary Outcome Measures
Name Time Method Severity of dementia based on the Functional Assessment Staging Test (FAST) 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 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.