臨床研究等提出・公開システム

Date of registration	June. 01, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221473

Scientific Title	Open-label study to assess efficacy and safety of a single dose (i.v.) of NMA78 in patients with Dementia with Lewy Bodies (DLB) or Alzheimer's Disease (AD) and healthy volunteers (HV)
Public Title	Open-label study to assess efficacy and safety of a single dose (i.v.) of NMA78 in DLB or AD patients and HV

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Nihon Medi-Physics Co., Ltd.
	Address	kan_kubomura@nmp.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Nihon Medi-Physics Co., Ltd.
	Address	03-5634-7434
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		18
Study Type		Interventional
Study Design	Study Design	Non-randomized, open-label
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	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.
	Minimum Age	35age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		DLB, AD
Intervention(s)		investigational material(s) Generic name etc : NMA78 INN of investigational material : ioflupane(123I) Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines) Dosage and Administration for Investigational material : intravenous injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety: subjective/objective symptoms, vital signs, electrocardiogram, clinical tests Efficacy: diagnostic accuracy by reading committee
Secondary Outcome		Efficacy: diagnostic accuracy by medical institutions, interpretation reproducibility, dosage and administration, semiquantitative index

Primary Sponsor	Nihon Medi-Physics Co., Ltd.
Secondary Sponsor	None

Name of Funding Organization	Nihon Medi-Physics Co., Ltd.
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-111512
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	July. 31, 2014	Detail	Changes
9	July. 31, 2014	Detail	Changes
8	May. 10, 2012	Detail	Changes
7	May. 10, 2012	Detail	Changes
6	Dec. 28, 2011	Detail	Changes
5	Dec. 28, 2011	Detail	Changes
4	Dec. 27, 2011	Detail	Changes
3	Dec. 27, 2011	Detail	Changes
2	June. 01, 2011	Detail	Changes
1	June. 01, 2011	Detail

List of change history