臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 23, 2019
Last modified on	June. 16, 2021
Trial ID	jRCTs051190065

Scientific Title	Exploratory clinical study on usefulness of tau PET imaging on diagnosis and evaluation of preclinical- and prodromal-stage Alzheimer's disease
Public Title	AMED Preclinical tau PET study

Completion date	April. 24, 2020
Result actual enrolment	15
Baseline Characteristics	Age : Mean 76 y.o. (Range 65 - 84 y.o) Sex : 9 males. 6 females. Breakdown by Group Cognitively unimpaired : 10 subjects Mild cognitive impairment (MCI) 5 subjects
Participant flow	This study is an add-on study to the "AMED Preclinical Study Project" and the subjects are those who were registered to the mother study and who gave informed consent to participating in this study. A total of 15 subjects from 8 sites participated and underwent a tau PET scan with in-house produced 18F-AV-1451 (flortaucipir) at a total of three PET sites. The PET camera was qualified with the phantom test, by which the scanning parameters were determined to satisfy the image quality criteria.
Adverse events	None
Outcome measures	Primary outcome : Quality of 18F-AV-1451 and PET image quality The 18F-AV-1451 was produced on-site as an in-house PET drug with the quality compliant with the criteria for every batch. All the PET images and accompanying data passed the quality check. Secondary outcome 1 : Safety of tau PET with 18F-AV-1451 No adverse events were observed. Secondary outcome 2 : Brain uptake of 18F-AV-1451 Qualitative evaluation of the PET images revealed that 3 subjects (all with MCI) showed abnormal cortical uptake patterns characteristic of Alzheimer's disease (AD) process. Quantitative analysis indicated higher cortical tau deposition for MCI than for the cognitively unimpaired.
Brief summary	A total of 15 subjects with the age 65-84 (10 cognitively unimpaired and 5 mild cognitive impairment (MCI)) underwent a tau-PET scan with 18F-AV-1451. All the PET images and related data passed the quality check. No adverse events were observed. Qualitative evaluation of the PET images revealed that 3 subjects (all with MCI) showed abnormal cortical uptake patterns characteristic of AD process. Quantitative analysis indicated higher cortical uptake for MCI than for the cognitively unimpaired.
Date of posting of results summaries	April. 09, 2021
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	No plans
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs051190065

Contact for Scientific Queries	Name	Shimada Hiroyuki
	Affiliation	Osaka City University Hospital
	Address	1-4-3 Asahimachi Abenoku Osaka city Osaka
	Telephone	+81-6-6646-6185
	E-mail	h.shimada@med.osaka-cu.ac.jp
Contact for Public Queries	Name	Shimada Hiroyuki
	Affiliation	Osaka City University Graduate School of Medicine.
	Address	1-4-3 Asahimachi Abenoku Osaka city Osaka
	Telephone	+81-6-6646-6185
	E-mail	h.shimada@med.osaka-cu.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 23, 2019
Actual date of first enrollment
Target sample size		40
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.Subjects who are enrolled in the AMED Preclinical study 2.Informed consent to participate in this tau PET study 3.Able to undergo the tau PET scan within 2 years from the baseline visit of the AMED Preclinical study
	Exclusion Criteria	1.Subjects who should not undergo the tau PET scan as judged by the physician in charge. 2.Subjects who will not be able to complete the tau PET scan
	Age Minimum	60age old over
	Age Maximum	85age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Preclinical AD, Mild Cognitive Impairment (MCI)
Intervention(s)		PET scan using an unapproved PET drug
Health Condition(s) Keyword		Dementia Alzheimer disease
Intervention(s) Keyword		Positron emission tomography
Health Condition(s) Code		F00, G30
Intervention(s) Code		D000072760
Primary Outcome(s)		Tau PET
Secondary Outcome(s)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Fidelity Foundation
Secondary Sponsor	Not applicable

Source of Monetary Support	Alzheimer Association
Secondary Sponsor	Not applicable

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Osaka City University Hospital Certified Review Board
Address	1-5-7 Asahi-machi Abeno-ku Osaka-city Abeno Medics 6th floor, Osaka
Telephone	+81-6-6645-3456
E-Mail	irb@med.osaka-cu.ac.jp
Approval Status	Approval
Date of approval	Sept. 05, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	June. 16, 2021	(this page)	Changes
4	Mar. 05, 2021	Detail	Changes
3	Feb. 25, 2021	Detail	Changes
2	Dec. 18, 2019	Detail	Changes
1	Oct. 23, 2019	Detail

List of change history