DLB-Z
- Conditions
- Dementia with Lewy bodies
- Registration Number
- JPRN-jRCTs041180125
- Lead Sponsor
- Washimi Yukihiko
- Brief Summary
The results of the present study showed no trend for improvement in the BPSD of DLB with zonisamide, which was seen in our exploratory study, based on the amount of change in NPI after 2 and 4 weeks, and zonisamide was not shown to be effective against the BPSD of DLB.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 25
1 Probable DLB with the criteria of DLB workshop 2005
2 BPSD is present on NPI
3 MMSE score 10 26
4 WBC platelet Serum AST ALT ALP GTP level should be in normal range
5 Have a study partner able to provide an independent evaluation of functioning
6 Agreement to sign an informed consent
1 Patient with non DLB.
2 No focal lesion exists in brain MRI.
3 Has current serious illness, psychiatric problem or drug abuse.
4 Those who have used Zonisamide over before.
5 Those who have joined any clinical trial within 3 month.
6 Those who have received medications that affected the central nervous system within 4 weeks.
7 Dose of chronic medications that affect CNS should be stable for at least 4 weeks before Visit0.
8 Those who are judged inadequate by their doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method