Present status of clinical trials on MCI (mild cognitive impairment)

Yu Nakamura

Department of Neuropsychiatry, Kagawa University School of Medicine

MCI (mild cognitive impairment) is being focused, and several large clinical trials on MCI have been held in Europe and USA. However, indication of MCI has been never admitted by regulators, and a few clinical trials on MCI are now going on. The large multi-center trial organized by ADCS had been carried out, and showed that donepezil could prevent the conversion of MCI to AD only in Apo E4 allele positive patients. Clinical trials on MCI have a lot of issues such as definition of MCI, pharmaco-genotyping, long observation period and surrogate endpoints, and the issues must be solved for development of anti-MCI drugs.

Address correspondence to Dr. Yu Nakamura, Department of Neuropsychiatry, Kagawa University School of Medicine (1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan)