Clinical trial NCT02262975: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 532
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment discontinuation Rate
timeFrame: Up to 1 year
Secondary outcomes:
measure: Factors leading to donepezil treatment discontinuation
timeFrame: Up to 1 year
measure: Mean change in treatment duration
timeFrame: Up to 1 year
measure: Percent change in treatment regimen
timeFrame: Up to 1 year
measure: Mean change in the scores of cognitive assessments test
timeFrame: Baseline, Visit 4 [Month 6], and Visit 5: [Year 1]
measure: Compliance of donepezil: Clinical Rating Scale (CRS)
timeFrame: Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]
measure: Compliance of donepezil: Visual Analog Scale (VAS)
timeFrame: Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1]
Other outcomes:
Locations:
city: Beijing
country: China
city: Gangwon
country: China
city: Hong Kong
country: China
city: Nanjing
country: China
city: Shaanxi
country: China
city: Shanghai
country: China
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gyeonggi
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeonju
country: Korea, Republic of
city: Kangwon
country: Korea, Republic of
city: Seongnam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Manila
country: Philippines
city: Singapore
country: Singapore
city: Bangkok
country: Taiwan
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: New Taipei
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Shanghai
country: Thailand
Study officials:
References:
citation: 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.