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

Alzheimer's Desease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162251
• Other study ID #: ART07T
• Status: Completed
• Start date: June 1, 2013
• Est. completion date: April 15, 2016

Study information

• Verified date: December 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3482
• Est. completion date: April 15, 2016
• Est. primary completion date: May 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Desease

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 (2)

Geriatric Medicine 55(1): 87-100, 2017.

Geriatric Medicine 55(11): 1251-1264, 2017.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigations on adverse events and adverse drug reactions		Up to 12 months
Secondary	Severity of dementia based on the Functional Assessment Staging Test (FAST)	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	Baseline, Month 3, Month 6, and Month 12
Secondary	Change From Baseline in the Mini-Mental State Examination (MMSE) Score	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.	Baseline and Month 12