Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
This study has been completed.
Sponsor:
Samsung Medical Center
Collaborator:
Eisai Korea Inc.
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01023867
First received: November 30, 2009
Last updated: January 4, 2016
Last verified: January 2016
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Purpose
To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease Dementia |
Drug: donepezil |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia |
Resource links provided by NLM:
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
Secondary Outcome Measures:
- Seoul Activities of Daily Living (S-ADL) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
- Seoul-Instrumental Activities of Daily Living (S-IADL) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
- Korean Neuropsychiatric Inventory (K-NPI) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
| Enrollment: | 88 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Alzheimer's disease group
Patients with Alzheimer's disease treated donepezil
|
Drug: donepezil
from 5mg to 10mg, once a day, 12 months
Other Name: donepezil-aricept
|
|
Experimental: Mixed Dementia group
Patients with Mixed Dementia treated donepezil
|
Drug: donepezil
from 5mg to 10mg, once a day, 12 months
Other Name: donepezil-aricept
|
Detailed Description:
The purposes of this study are:
- to compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia
- to help to clinicians in choosing the best treatment for patients with mixed dementia
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
- Korean version Mini-Mental State Examination scores between 10 and 26
- History of cognitive decline that had been gradual in onset and progressive over at least 6 months
- A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Exclusion Criteria:
- they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
- Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
- Cerebral injuries induced by trauma, hypoxia, and/or ischemia
- Clinically active cerebrovascular disease; History of seizure disorder
- Other physical conditions that required acute treatment.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023867
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023867
Locations
| Korea, Republic of | |
| Samsung Medical Center | |
| Seoul City, Korea, Republic of, 135-710 | |
Sponsors and Collaborators
Samsung Medical Center
Eisai Korea Inc.
Investigators
| Principal Investigator: | Doh Kwan Kim, PhD, M.D. | Samsung Medical Center |
More Information
| Responsible Party: | Doh Kwan Kim, Professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01023867 History of Changes |
| Other Study ID Numbers: |
2007-03-039 |
| Study First Received: | November 30, 2009 |
| Last Updated: | January 4, 2016 |
Keywords provided by Samsung Medical Center:
|
Alzheimer's disease Mixed Dementia Donepezil Efficacy Adverse Event |
Additional relevant MeSH terms:
|
Alzheimer Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Dementia Tauopathies |
Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents |
ClinicalTrials.gov processed this record on May 22, 2017