Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23mg
NCT ID: NCT02550665
Last Updated: 2018-08-07
Study Results
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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COMPLETED
PHASE3
176 participants
INTERVENTIONAL
2014-12-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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donepezil 15mg titration
donepezil 15mg during the first 4 weeks before escalation to 23mg
donepezil
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
donepezil 10mg & 23 mg alternating
alternating donepezil 10mg and 23mg during the first 4 weeks before escalation to 23mg
donepezil
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
no titration of donepezil
no titration and direct escalation to 23mg donepezil
donepezil
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
Interventions
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donepezil
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* probable Alzheimer's disease dementia according to National Institute on Aging-Alzheimer's Association (NIAAA) criteria
* Mini-Mental State Examination (MMSE) score of 20 or less
* General Deterioration Scale (GDS) score of 4 or more / Clinical Dementia Rating (CDR) score of 2 or more
* stable dose of 10mg donepezil at least 3 months before screening
* caregiver who can come together at every visit and give informations about side effects profiles should exist
* patients and caregivers accepted the study
Exclusion Criteria
* uncontrolled psychiatric disorders
* drug overuse or alcohol abuse history within 5 years
* significant uncontrolled or active medical conditions
* uncontrolled epilepsy
* patients who cannot come at scheduled visits
45 Years
90 Years
ALL
No
Sponsors
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Dong-A University
OTHER
Myongji Hospital
OTHER
Seoul National University Bundang Hospital
OTHER
Seoul St. Mary's Hospital
OTHER
Chung-Ang University
OTHER
Eisai Inc.
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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Jae-Hong Lee
Principal investigator
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Hong YJ, Han HJ, Youn YC, Park KW, Yang DW, Kim S, Kim HJ, Kim HJ, Lee Y, Kwon M, Lee JH; ODESA study (Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23 mg). Effects of Body Weight on the Safety of High-Dose Donepezil in Alzheimer's Disease: Post hoc Analysis of a Multicenter, Randomized, Open-Label, Parallel Design, Three-Arm Clinical Trial. Dement Geriatr Cogn Disord. 2021;50(3):289-295. doi: 10.1159/000518470. Epub 2021 Sep 10.
Hong YJ, Han HJ, Youn YC, Park KW, Yang DW, Kim S, Kim HJ, Kim JE, Lee JH; ODESA study (Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23 mg). Safety and tolerability of donepezil 23 mg with or without intermediate dose titration in patients with Alzheimer's disease taking donepezil 10 mg: a multicenter, randomized, open-label, parallel-design, three-arm, prospective trial. Alzheimers Res Ther. 2019 May 1;11(1):37. doi: 10.1186/s13195-019-0492-1.
Other Identifiers
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JHongLee
Identifier Type: -
Identifier Source: org_study_id
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