Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Samsung Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
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: June 26, 2012
Last verified: June 2012
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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 Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Seoul Activities of Daily Living (S-ADL) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
- Seoul-Instrumental Activities of Daily Living (S-IADL) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
- Korean Neuropsychiatric Inventory (K-NPI) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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| Genders Eligible for Study: | Both |
| 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
Contacts
| Contact: Doh Kwan Kim, PhD., M.D. | 82-2-3410-3582 | paulkim@skku.edu | |
| Contact: Hyo Shin Kang, M.A. | 82-2-3410-0928 | hyoshin.kang@sbri.co.kr |
Locations
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul City, Korea, Republic of, 135-710 | |
| Contact: DohKwan Kim, M.D.,Ph.D. 82-2-3410-3582 paulkim@skku.edu | |
Sponsors and Collaborators
Samsung Medical Center
Eisai Korea Inc.
Investigators
| Principal Investigator: | Doh Kwan Kim, PhD, M.D. | Samsung Medical Center |
More Information
No publications provided
| 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: | June 26, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
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 Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Neurodegenerative Diseases Dementia Tauopathies Donepezil |
Central Nervous System Agents Cholinergic Agents Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Nootropic Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015