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| Name | Class |
|---|---|
| Dong-A University | OTHER |
| Myongji Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Seoul St. Mary's Hospital |
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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.
High dose of donepezil is currently prescribed for patients with Alzheimer's disease who showed poor response in lower dose, however the side effect profiles according to dose titration method were not clarified yet. This study aims to confirm which titration method would show better safeties and tolerabilities in the high dose donepezil treatment. Investigators include patients with moderate to severe dementia who were diagnosed as probable Alzheimer's disease and treated with donepezil 10mg at least 3 months before the study. The study duration is for 12 weeks and the titration duration is the first 4 weeks of the study. Investigators evaluate the side effects profiles and vital signs at every 4 weeks and measure blood laboratory tests at screening and the last visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| donepezil 15mg titration | Experimental | donepezil 15mg during the first 4 weeks before escalation to 23mg |
|
| donepezil 10mg & 23 mg alternating | Experimental | alternating donepezil 10mg and 23mg during the first 4 weeks before escalation to 23mg |
|
| no titration of donepezil | Active Comparator | no titration and direct escalation to 23mg donepezil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donepezil | Drug | using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| blood WBC | if WBC count is below 4000/uL or above 10000/uL, abnormal | 12 week |
| blood BUN | if BUN level is above 30 mg/dL, abnormal | 12 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34518459 | Derived | 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. | |
| 31039806 |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| OTHER |
| Chung-Ang University | OTHER |
| Eisai Inc. | INDUSTRY |
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|
| blood Creatinine | if creatinine level is above 1.4 mg/dL, abnormal | 12 week |
| blood sodium | if sodium level is below 135mmol/L or above 145mmol/L, abnormal | 12 week |
| blood potassium | if potassium level is below 3.5mmol/L or above 5.1mmol/L, abnormal | 12 week |
| blood AST/ALT | if AST or ALT level is above 50 IU/L, abnormal | 12 week |
| weight loss | if the weight is decreased over 5% of body weight at screening visit, then weight loss | 4 week, 8 week, 12 week |
| drug compliance (counting of residual drug) | if the (number of prescribed drugs - number of residual drugs)/ number of prescribed drugs is below 80%, then consider as low compliance, if compliance is between 80-100% then consider as good compliance | 4 week, 8 week, 12 week |
| heart rate on Electrocardiography (ECG) | checking whether heart rate on ECG is normal because donepezil can cause bradycardia; if the heart rate is decreased below 50, then write down as bradycardia | 12 week |
| Derived |
| 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. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |