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
This trial is active, not recruiting.
|Sponsor||Eisai Co., Ltd.|
|Start date||June 2013|
|End date||August 2015|
|Trial size||5000 participants|
|Trial identifier||NCT02162251, ART07T|
To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice.
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
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
time frame: Baseline and Month 12
Male or female participants of any age.
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.
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