今日の国際共同研究における臨床評価尺度と認知機能検査

Current Clinical Assessment Scales and Cognitive Tests in Global Clinical Studies on Alzheimer's Disease

アルツハイマー病の臨床研究では，臨床症状と認知機能障害を定量化して重症度を記載するため，臨床評価尺度と認知機能検査が用いられる。近年，プレクリニカル期アルツハイマー病や軽度認知障害を対象とした研究が増え，使用されるスケールも変化している。国際共同研究では難易度を等しく保ちながら翻訳し，標準化を行う過程が必要である。また，多施設共同研究では手順の画一化を図り，質の高いデータを得る工夫も重要である。

Abstract

To quantify the severity of clinical symptoms and cognitive dysfunction, clinical assessment scales and cognitive tests are used in clinical studies involving patients with Alzheimer's disease (AD). As an increasing number of clinical studies involving individuals with preclinical AD and mild cognitive impairment are being conducted, newly developed scales are also utilized in those studies. Scales and tests must be translated into Japanese and validated, with the level of difficulty kept equal to the original, in order to obtain data comparable to those of other countries, in global studies. Moreover, the uniformity of procedures in test administration is crucial to procuring high-quality data in multicenter clinical studies. Such background efforts, which support novel scientific findings, as well as clinical assessment scales and cognitive tests which are used in recent studies are described in this section.