Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease - NaT-PROBEi

Katsuno Masahisa0 个研究点目标入组 30 人开始时间: 2020年3月10日最近更新: 2023年10月17日

试验速览

暂无简介。

•1. Subjects whose age is between 50 and 80 years old
•2. Subjects who have two or more prodromal symptoms:
•SCOPA-AUT: 10 or more
•RBDSQ: 5 or more, or REM sleep without atonia (RWA) finding of polysomnography
•OSIT-J: 7 or less, or SAOQ: 90% or less
•3. Subjects who fulfill one of the following criteria:
•In cardiac MIBG scintigraphy, H/M ratio is less than 2.2 in early-phase and/or delayed-phase
•In DaT SPECT, SBR is lower than the limit of z-score for each age using DaTVIEW analysis (left and/or right side), or DAT deficiency in the striatum
•4. Subjects who can make an outpatient visit regularly
•5. Subjects who agree to participate in this study

•1. Subjects who received zonisamide within 4 weeks from screening
•2. Subjects with hypersensitivity to TRERIEF
•3. Subjects who take medicine which affect blood concentration of zonisamide: strong inhibitors of CYP3A
•4. Subjects with severe heart disease (myocardial infarction, angina, etc)
•5. Subjects with severe hepatic or renal dysfunction
•6. Subjects diagnosed with Parkinson's disease or dementia with Lewy body
•7. Subjects with mental or neurological disorders other than depression
•8. Subjects with other severe complications
•9. Female subjects who are pregnant or breast-feeding, those with positive urine hCG pregnancy test
•10. Subjcets who disagree with contraception during the study period
•11. Subjects diagnosed with dementia or other neurological disorders using brain MRI at screening
•12. Subjects who are inappropriate to participate in the study
•13. Subjects who received other investigational drugs within 1 year
•14. Subjects who participate in other clinical trials. Prospective study on early diagnosis of Parkinson's disease in medical checkup examinees with non-motor symptoms (NaT-PROBE) is excluded.

发起方

Katsuno Masahisa