Comparative Assessment of Clinical Efficacy after 12-Month Clinical Trial of Donepezil between the Patients with Pure Alzheimer's Disease and Mixed Dementia.
- Author:
Hyo Shin KANG
1
;
Inn Sook AHN
;
Ji Hae YUN
;
Yu Jin MOON
;
Tae Young HWANG
;
Young Min LEE
;
Hyeran KIM
;
Jae Won CHUNG
;
Doh Kwan KIM
Author Information
1. Clinical Research Center, Samsung Biomedical Research Institute, Samsung Medical Center, Seoul, Korea. paulkim@skku.edu
- Publication Type:Clinical Trial ; Original Article
- Keywords:
Alzheimer's Disease;
Mixed Dementia;
Donepezil;
Treatment response
- MeSH:
Activities of Daily Living;
Alzheimer Disease;
Dementia;
Humans;
Indans;
Piperidines
- From:Journal of Korean Geriatric Psychiatry
2010;14(1):58-64
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
OBJECTIVES: The purpose of this study was to compare the efficacy of donepezil treatment between patients with pure Alzheimer's disease (AD) and Mixed dementia (MD) during a 12-month trial. METHODS: A total of 139 patients were recruited for this 52-week study. The effect of donepezil on cognitive function was measured using Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K). Patients' activities of daily living using the Seoul-Instrumental Activities of Daily Living (S-IADL) and Seoul-Activities of Daily Living (S-ADL);behavioral symptoms using the Korean version Neuropsychiatric Inventory (K-NPI) were measured at baseline, 13-weeks, 26-weeks, 39-weeks and 52-weeks. We defined the responsive patients to donepezil at those who showed a cognitive improvement or no change during the first six-month clinical trial. RESULTS: 84 pure AD patients and 34 MD patients were available for intent-to-treat (ITT) last observation carried forward (LOCF) analysis. There was no significant difference between two groups in mean change from baseline in the total ADAS-cog-k, S-ADL, S-IADL and K-NPI scores at 52-week. Based on the operational criteria, 60.7% of pure AD patients and 58.8% of MD patients were responders to donepezil. CONCLUSION: MD patients had similar levels of efficacy with pure AD patients and donepezil was well tolerated in both groups. These results suggest that donepezil is an effective and well-tolerated treatment for MD patients as well as for pure AD patients.
