Open-label study to assess efficacy and safety of a single dose (i.v.) of NMA78 in DLB or AD patients and HV
Phase 3
- Conditions
- DLB, AD
- Registration Number
- JPRN-jRCT2080221473
- Lead Sponsor
- ihon Medi-Physics Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
[HV]
-Healthy Japanese people.
[DLB]
-Japanese patients clinically- diagnosed with DLB.
[AD]
-Japanese patients clinically- diagnosed with AD.
Exclusion Criteria
-People using following drugs: cocaine hydrochloride, mazindol, methylphenidate hydrochloride, sertraline hydrochloride.
-Patients with hepatic, renal or hematopoietic dysfunction.
-People with allergic reaction to alcohol or iodine.
-Women who are pregnant, lactating or possibly pregnant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: subjective/objective symptoms, vital signs, electrocardiogram, clinical tests<br>Efficacy: diagnostic accuracy by reading committee
- Secondary Outcome Measures
Name Time Method Efficacy: diagnostic accuracy by medical institutions, interpretation reproducibility, dosage and administration, semiquantitative index