Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23mg
ODESA
A Multicenter, Randomized, Open-label, Prospective Trial to Evaluate the Safety and Tolerability of Donepezil 23 mg With or Without Intermediate Dose Titration in Patients With Alzheimer's Disease Taking Donepezil Hydrochloride 10 mg
1 other identifier
interventional
176
1 country
1
Brief Summary
This study evaluates the side effects of dose escalation in the treatment of donepezil 23mg for patients with Alzheimer's disease. Investigators randomly divide participants into three groups according to the dose escalation method; no titration, 15mg of donepezil for a month before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to 23mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedAugust 7, 2018
August 1, 2018
1.7 years
September 10, 2015
August 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events (safety and tolerability)
adverse events (nausea, vomiting, diarrhea, anorexia, abdominal pain, headache and other unpredicted adverse events)are asked and assessed using 3 grade scale (mild, moderate, severe)
Change from baseline at 4 week
Secondary Outcomes (9)
blood WBC
12 week
blood BUN
12 week
blood Creatinine
12 week
blood sodium
12 week
blood potassium
12 week
- +4 more secondary outcomes
Study Arms (3)
donepezil 15mg titration
EXPERIMENTALdonepezil 15mg during the first 4 weeks before escalation to 23mg
donepezil 10mg & 23 mg alternating
EXPERIMENTALalternating donepezil 10mg and 23mg during the first 4 weeks before escalation to 23mg
no titration of donepezil
ACTIVE COMPARATORno titration and direct escalation to 23mg donepezil
Interventions
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
Eligibility Criteria
You may qualify if:
- dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV 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
You may not qualify if:
- patients receiving other concomitant acetylcholinesterase inhibitor
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asan Medical Centerlead
- Dong-A Universitycollaborator
- Myongji Hospitalcollaborator
- Seoul National University Bundang Hospitalcollaborator
- Seoul St. Mary's Hospitalcollaborator
- Chung-Ang Universitycollaborator
- Eisai Inc.collaborator
Study Sites (1)
Asan Medical Center
Seoul, 05505, South Korea
Related Publications (2)
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.
PMID: 34518459DERIVEDHong 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.
PMID: 31039806DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 15, 2015
Study Start
December 1, 2014
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
August 7, 2018
Record last verified: 2018-08