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)

NCT ID: NCT02262975

Last Updated: 2016-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

532 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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donepezil (Aricept)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing, , China

Site Status

Gangwon, , China

Site Status

Hong Kong, , China

Site Status

Nanjing, , China

Site Status

Shaanxi, , China

Site Status

Shanghai, , China

Site Status

Manila, , Philippines

Site Status

Singapore, , Singapore

Site Status

Busan, , South Korea

Site Status

Daegu, , South Korea

Site Status

Daejeon, , South Korea

Site Status

Gyeonggi-do, , South Korea

Site Status

Incheon, , South Korea

Site Status

Jeonju, , South Korea

Site Status

Kangwon, , South Korea

Site Status

Seongnam, , South Korea

Site Status

Seoul, , South Korea

Site Status

Bangkok, , Taiwan

Site Status

Changhua, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

New Taipei City, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Bangkok, , Thailand

Site Status

Shanghai, , Thailand

Site Status

Countries

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China Philippines Singapore South Korea Taiwan Thailand

References

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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.

Reference Type DERIVED
PMID: 33827446 (View on PubMed)

Other Identifiers

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ART-M082-602

Identifier Type: -

Identifier Source: org_study_id