Premium
Disease state changes and safety of long‐term donepezil hydrochloride administration in patients with A lzheimer's disease: interim results from the long‐term, large‐scale J‐GOLD study in J apan
Author(s) -
Arai Heii,
Sumitomo Kenta,
Sakata Yukinori,
Daidoji Kasumi,
Takase Takao,
Toyoda Tetsumi
Publication year - 2016
Publication title -
psychogeriatrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.647
H-Index - 32
eISSN - 1479-8301
pISSN - 1346-3500
DOI - 10.1111/psyg.12130
Subject(s) - donepezil , medicine , dementia , exacerbation , population , disease , alzheimer's disease , interim analysis , mini–mental state examination , gerontology , clinical trial , environmental health
Background There have been very few long‐term studies involving a large study population; existing studies usually have no more than a few hundred patients with A lzheimer's disease. For these reasons, there are no detailed investigations regarding changes in activities of daily living evaluated by the F unctional A ssessment S taging T est ( FAST ). Methods A long‐term, large‐scale observational study of donepezil hydrochloride ( A ricept ® ; E isai C o., L td, T okyo, J apan) is currently in progress. Its objective is to investigate disease state changes associated with the long‐term administration of this drug and its safety in patients with A lzheimer's disease. In this report, data collected over a maximum of 24 months were compiled. Efficacy was assessed using FAST and a cognitive function test ( M ini‐ M ental S tate E xamination or the H asegawa's D ementia S cale‐ R evised). Results The percentages of patients whose FAST stage improved or remained the same compared to at the start of donepezil hydrochloride administration (baseline) were 91.1% at 6 months, 83.0% at 12 months, 79.5% at 18 months, and 74.8% at 24 months. Multivariate logistic regression analysis was conducted to investigate factors that affect the improvement and maintenance or exacerbation of FAST at 24 months. ‘Independence level in the daily life of elderly with dementia’ and ‘duration of illness’ were identified as variables that affected the improvement and maintenance or exacerbation of FAST . Cognitive function improved significantly at 12 weeks and at 6 months compared to baseline, maintained baseline levels at 12 months and at 18 months, and decreased significantly at 24 months compared to baseline. Conclusions This is the largest prospective study involving A lzheimer's disease patients in J apan, and we believe it is an important study that shows the reality of daily clinical practice.