Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Factors That Affect Aricept Medication Persistence Rate and the Safety and Efficacy in Patients With Alzheimer's Disease in Clinical Practice

Alzheimer's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162264
• Other study ID #: ART08T
• Status: Completed
• Start date: June 1, 2013
• Est. completion date: July 22, 2016

Study information

• Verified date: January 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the factors that affect Aricept medication persistence rate and the safety and efficacy in patients with Alzheimer's Disease in clinical practice

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8662
• Est. completion date: July 22, 2016
• Est. primary completion date: May 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

Patients diagnosed with Alzheimer's Disease and administered Aricept for the first time.

Exclusion criteria:

Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Geriatric Medicine 55(10): 1131-1145, 2017.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Mini-Mental State Examination (MMSE) Score		Baseline, Month 3, Month 6, and Month 12
Secondary	Investigations on adverse events and adverse drug reactions		Baseline and Month 12