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) (ADOS)

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease

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 Type: Observational
• Enrollment (Actual): 532

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Gangwon, China
  • Hong Kong, China
  • Nanjing, China
  • Shaanxi, China
  • Shanghai, China
• Korea, Republic of
  • Busan, Korea, Republic of
  • Daegu, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Gyeonggi, Korea, Republic of
  • Incheon, Korea, Republic of
  • Jeonju, Korea, Republic of
  • Kangwon, Korea, Republic of
  • Seongnam, Korea, Republic of
  • Seoul, Korea, Republic of
• Philippines
  • Manila, Philippines
• Singapore
  • Singapore, Singapore
• Taiwan
  • Bangkok, Taiwan
  • Changhua, Taiwan
  • Kaohsiung, Taiwan
  • New Taipei, Taiwan
  • Taichung, Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan
• Thailand
  • Bangkok, Thailand
  • Shanghai, Thailand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Alzheimer's disease patients who have been recently prescribed with donepezil (Aricept) as monotherapy for the first time

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
donepezil (Aricept)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment discontinuation Rate	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors leading to donepezil treatment discontinuation	Reason for the subjects who discontinued the administration of donepezil (Aricept)	Up to 1 year
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)	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]
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]

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.

Publications and helpful links

General Publications

• Shim YS, Park KH, Chen C, Dominguez JC, Kang K, Kim HJ, Hong Z, Lin YT, Chu LW, Jung S, Kim S. Caregiving, care burden and awareness of caregivers and patients with dementia in Asian locations: a secondary analysis. BMC Geriatr. 2021 Apr 7;21(1):230. doi: 10.1186/s12877-021-02178-x.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Estimate): December 28, 2016
• Last Update Submitted That Met QC Criteria: December 23, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Alzheimer's disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: ART-M082-602