Overview

This trial is active, not recruiting.

Condition alzheimer's desease
Treatment donepezil hydrochloride
Sponsor Eisai Co., Ltd.
Start date June 2013
End date August 2015
Trial size 5000 participants
Trial identifier NCT02162251, ART07T

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
donepezil hydrochloride Aricept
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.

Primary Outcomes

Measure
Investigations on adverse events and adverse drug reactions
time frame: Up to 12 months

Secondary Outcomes

Measure
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

Eligibility Criteria

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.

Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Eisai Inc..