Lewy body disease (Parkinson's disease and dementia with Lewy bodies)
Conditions
Interventions
Arm zonisamide:
1.Two tablets of zonisamide 25mg after breakfast for 4 weeks
2.Four tablets of zonisamide 25mg after breakfast for 92 weeks
Arm placebo:
1.Two tablets of placebo after breakfast for
Sponsors
Katsuno Masahisa
Japan Agency for Medical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the average of SBR in the right and left sides in DaT SPECT from week 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of the following measures from 0 week: Change of SBR of each side in DaT SPECT MDS-UPDRS MoCA-J Trail making test Stroop test Line orientation test pareidolia test H/M ratio on cardiac MIBG scintigraphy OSIT-J Schellong test CVR-R on electrocardiogram PASE SCOPA-AUT-J RBDSQ-J PDQ-39 BDI-II SAOQ JESS QUIP-Current-Short 2. Subjects who fulfill the diagnostic criteria for Parkinson's disease or dementia with Lewy bodies | — |
Contacts
Public ContactKeita Hiraga
Nagoya University Graduate School of Medicine
Outcome results
None listed