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

Phase 2

• Conditions: ewy body disease (Parkinson's disease and dementia with Lewy bodies)

• Registration Number: JPRN-jRCTs041190126
• Lead Sponsor: Katsuno Masahisa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified