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Completed

NCT Number: 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)

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Greater than or equal to 50 years old and less than 90 years old
  • Diagnosed as probable AD based on NINCDS-ADRDA
  • Patients who have been recently prescribed with donepezil (Aricept) as monotherapy
  • Patients and caregivers who signed the written informed consent from for use of personal and medical information
  • Patients with caregivers who can visit the institution together

Exclusion criteria

  • Patients who have taken Memantine or Acetylcholinesterase (AChE) inhibitor prior to participating in the study

Treatment and study plan

Primary outcomes

  1. Treatment discontinuation Rate

    Time frame: Up to 1 year

Secondary outcomes

  1. Factors leading to donepezil treatment discontinuation

    Time frame: Up to 1 year

    Reason for the subjects who discontinued the administration of donepezil (Aricept)

  2. Mean change in treatment duration

    Time frame: Up to 1 year

  3. Percent change in treatment regimen

    Time frame: Up to 1 year

  4. Mean change in the scores of cognitive assessments test

    Time frame: Baseline, Visit 4 [Month 6], and Visit 5: [Year 1]

  5. Compliance of donepezil: Clinical Rating Scale (CRS)

    Time frame: 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.

  6. Compliance of donepezil: Visual Analog Scale (VAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Acronym: ADOS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2014
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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