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Trial record 8 of 331 for:    DONEPEZIL

Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23mg (ODESA)

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ClinicalTrials.gov Identifier: NCT02550665
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
Dong-A University
Myongji Hospital
Seoul National University Bundang Hospital
Seoul St. Mary's Hospital
Chung-Ang University
Eisai Inc.
Information provided by (Responsible Party):
Jae-Hong Lee, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: donepezil Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: donepezil 15mg titration
donepezil 15mg during the first 4 weeks before escalation to 23mg
Drug: donepezil
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
Other Name: aricept

Experimental: donepezil 10mg & 23 mg alternating
alternating donepezil 10mg and 23mg during the first 4 weeks before escalation to 23mg
Drug: donepezil
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
Other Name: aricept

Active Comparator: no titration of donepezil
no titration and direct escalation to 23mg donepezil
Drug: donepezil
using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
Other Name: aricept




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Change from baseline at 4 week ]
    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)


Secondary Outcome Measures :
  1. blood WBC [ Time Frame: 12 week ]
    if WBC count is below 4000/uL or above 10000/uL, abnormal

  2. blood BUN [ Time Frame: 12 week ]
    if BUN level is above 30 mg/dL, abnormal

  3. blood Creatinine [ Time Frame: 12 week ]
    if creatinine level is above 1.4 mg/dL, abnormal

  4. blood sodium [ Time Frame: 12 week ]
    if sodium level is below 135mmol/L or above 145mmol/L, abnormal

  5. blood potassium [ Time Frame: 12 week ]
    if potassium level is below 3.5mmol/L or above 5.1mmol/L, abnormal

  6. blood AST/ALT [ Time Frame: 12 week ]
    if AST or ALT level is above 50 IU/L, abnormal

  7. weight loss [ Time Frame: 4 week, 8 week, 12 week ]
    if the weight is decreased over 5% of body weight at screening visit, then weight loss

  8. drug compliance (counting of residual drug) [ Time Frame: 4 week, 8 week, 12 week ]
    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

  9. heart rate on Electrocardiography (ECG) [ Time Frame: 12 week ]
    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



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550665


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Dong-A University
Myongji Hospital
Seoul National University Bundang Hospital
Seoul St. Mary's Hospital
Chung-Ang University
Eisai Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae-Hong Lee, Principal investigator, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02550665     History of Changes
Other Study ID Numbers: JHongLee
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Keywords provided by Jae-Hong Lee, Asan Medical Center:
Alzheimer's disease
donepezil
Additional relevant MeSH terms:
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Donepezil
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents