DLB-Z

JRCT ID: jRCTs041180125

Registered date:23/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dementia with Lewy bodies
• Date of first enrollment: 04/10/2017
• Target sample size: 90
• Study type: Interventional

Intervention(s)

Arm zonisamide 100 mg : zonisamide 100 mg / day + lactose 0.5 g / day given on for 4 weeks.
Arm placebo : lactose 1.0 g / day given on for 4 weeks.

Outcome(s)

• Primary Outcome: Neuropsychiatric Inventory

Secondary Outcome

Mini Mental State Examination
Cognitive Fluctuation Inventory
Unified parkinson's Disease Rating Scale part3
Rescue medicine

Key inclusion & exclusion criteria

• Age minimum: >= 55age old
• Age maximum: <= 84age old
• Gender: Both

Include criteria

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

Exclude criteria

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.

Related Information

• Primary Sponsor: Washimi Yukihiko
• Source(s) of Monetary Support: National Center for Geriatrics and Gerontology
• Secondary ID(s): UMIN000027312