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)

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT02262975
• Lead Sponsor: Eisai Korea Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-23
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 532

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment discontinuation Rate	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
Factors leading to donepezil treatment discontinuation	Up to 1 year	Reason for the subjects who discontinued the administration of donepezil (Aricept)
Mean change in treatment duration	Up to 1 year
Percent change in treatment regimen	Up to 1 year
Mean change in the scores of cognitive assessments test	Baseline, Visit 4 [Month 6], and Visit 5: [Year 1]
Compliance of donepezil: Clinical Rating Scale (CRS)	Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]	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.
Compliance of donepezil: Visual Analog Scale (VAS)	Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]	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.