A Multi-national Study to Identify Treatment Discontinuation Rate in de Novo Alzheimer's Disease Patients Who Have Been Newly Prescribed With Donepezil (Aricept) in Asia (ADOS)

Alzheimer's Disease Clinical Trial

— ADOS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262975
• Other study ID #: ART-M082-602
• Status: Completed
• Phase: N/A
• First received: August 26, 2014
• Last updated: December 23, 2016
• Start date: July 2014
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial Summary

This study is an observational study conducted prospectively under routine clinical setting for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected institutions of about 8 countries in Asia.

Description:

Participation in this study places no additional visit schedule, which will be determined by the investigator's judgment based on the disease progression of each subject. Investigators educate subjects to keep decided visit schedule, and collect the required information for case record from (CRF) on the visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Greater than or equal to 50 years old and less than 90 years old

2. Diagnosed as probable AD based on NINCDS-ADRDA

3. Patients who have been recently prescribed with donepezil (Aricept) as monotherapy

4. Patients and caregivers who signed the written informed consent from for use of personal and medical information

5. Patients with caregivers who can visit the institution together

Exclusion Criteria:

1) Patients who have taken Memantine or Acetylcholinesterase (AChE) inhibitor prior to participating in the study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Countries where clinical trial is conducted

China,  Korea, Republic of,  Philippines,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment discontinuation Rate		Up to 1 year	No
Secondary	Factors leading to donepezil treatment discontinuation	Reason for the subjects who discontinued the administration of donepezil (Aricept)	Up to 1 year	No
Secondary	Mean change in treatment duration		Up to 1 year	No
Secondary	Percent change in treatment regimen		Up to 1 year	No
Secondary	Mean change in the scores of cognitive assessments test		Baseline, Visit 4 [Month 6], and Visit 5: [Year 1]	No
Secondary	Compliance of donepezil: Clinical Rating Scale (CRS)	CRS is a compliance scale ranged from 1 to 7. The higher score implies the higher compliance. 5 points or higher is defined as compliance, while 4 points or lower as non-compliance.	Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]	No
Secondary	Compliance of donepezil: Visual Analog Scale (VAS)	VAS is a tool to determine the compliance through interview between investigators and subjects based on drug administration during previous 4 weeks. The range is from 0 to 100.	Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]	No