Alzheimer's Desease
Conditions
Keywords
Alzheimer's Disease, donepezil hydrochloride
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.
Interventions
DRUGDonepezil 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.
Sponsors
Eisai Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigations on adverse events and adverse drug reactions | Up to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Outcome results
None listed