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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02262975

Acronym

ADOS

Enrollment

532

Registered

2014-10-13

Start date

2014-07-31

Completion date

2016-08-31

Last updated

2016-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Treatment discontinuation Rate	Up to 1 year

Secondary

Measure	Time frame	Description
Mean change in treatment duration	Up to 1 year	—
Percent change in treatment regimen	Up to 1 year	—
Factors leading to donepezil treatment discontinuation	Up to 1 year	Reason for the subjects who discontinued the administration of donepezil (Aricept)
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.
Mean change in the scores of cognitive assessments test	Baseline, Visit 4 [Month 6], and Visit 5: [Year 1]	—

Countries

China, Philippines, Singapore, South Korea, Taiwan, Thailand

Outcome results