Trial record 20 of 1245 for:
alzheimer
Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
This study is currently recruiting participants.
Verified June 2012 by Samsung Medical Center
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
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 Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013