Urinary Occult Blood Tests In Healthy Male and Female Volunteers From Three Different Age Groups

Abstract

August 2015 e29 Sugioka Memorial Hospital, Souseikai Global Clinical Research Center, Fukuoka, Japan; Hakata Clinic, Souseikai Global Clinical Research Center, Fukuoka, Japan; and Sumida Hospital, Souseikai Global Clinical Research Center, Tokyo, Japan Background: Cerebrospinal fluid (CSF) evaluation helps us to understand the CNS penetration, PK characteristics, as well as the PK/ PD relations of investigational drugs. It also gives us lots of intraneuronal information, especially in the areas of psychiatry and neurology. Therefore, sampling of CSF became a common procedure in healthy subjects in a broad range of CNS drug development as part of phase 1 clinical studies worldwide. However, in contrast to the fact that clinical studies on neurological disorders of elderly people have risen considerably, CSF sampling had been limited to only patients in Japan. Material and Methods: For the first time in Japan, we conducted a clinical trial involving CSF sampling by lumbar puncture in cognitively and physically healthy Japanese elderly volunteers. Thirty-two healthy elderly female and male volunteers (age, 55–71 y) from our panel participated in this study after given a thorough explanation about the procedure. We also performed a survey about the CSF sampling on healthy elderly people in order to evaluate the possibility of future clinical studies with CSF assessment in Japan. Results: CSF sampling by lumbar puncture in healthy Japanese elderly volunteers was completed without any serious adverse events. We found that the total protein level in CSF was higher in elderly volunteers than the reference level for adults. On the other hand, the survey results show that more than two thirds of the healthy Japanese elderly people are willing to undertake lumbar puncture for clinical studies in the future. Conclusion: As we anticipate that the markets for both drug development and drug consumption in elderly people will continue to grow, it is necessary to consider the establishment of reference values for healthy elderly regarding CSF. Our results indicate that the CSF sampling in healthy elderly volunteers can be successfully conducted in Japan to meet global needs.