Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
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ClinicalTrials.gov Identifier: NCT01023867 |
Recruitment Status
:
Completed
First Posted
: December 2, 2009
Last Update Posted
: January 6, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease Dementia | Drug: donepezil | Not Applicable |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 88 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K) [ Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks ]
- 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 ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT01023867
Korea, Republic of | |
Samsung Medical Center | |
Seoul City, Korea, Republic of, 135-710 |
Principal Investigator: | Doh Kwan Kim, PhD, M.D. | Samsung Medical Center |
Responsible Party: | Doh Kwan Kim, Professor, Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT01023867 History of Changes |
Other Study ID Numbers: |
2007-03-039 |
First Posted: | December 2, 2009 Key Record Dates |
Last Update Posted: | January 6, 2016 |
Last Verified: | January 2016 |
Keywords provided by Doh Kwan Kim, 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 |