臨床研究等提出・公開システム

Japanese

Date of registration	April. 09, 2013
Last modified on	Aug. 07, 2018
Trial ID	jRCT1091220124

Scientific Title	[18F]-flutemetamol amyloid imaging along the continuum from normal cognitive status to Alzheimer's disease dementia.
Public Title	[18F]-flutemetamol amyloid imaging along the continuum from normal cognitive status to Alzheimer's disease dementia.

Study end date
Performed Number of Subjects
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Participant Flow
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Efficacy Conclusions
Discussion and Overall Conclusions
Posted Date
Date of First Publication
Results Links

Plan to Share IPD
Plan Description
Protocol Links

Contact for Scientific Queries	Investigator Name	Shizuo Hatashita
	Investigator Organization	Shonan-Atsugi Hospital
	Address	113-1 nurumizu atsugi
	TEL	+81-46-223-3636
	E-mail	hatashita@shonan-atsugi.jp
Contact for Public Queries	Contact Name	Shizuo Hatashita
	Contact Organization	Shonan-Atsugi Hospital
	Address	113-1 nurumizu atsugi
	TEL	+81-46-223-3636
	E-mail	hatashita@shonan-atsugi.jp

Recruitment Status	COMPLETED

Date of First Enrollment		June. 01, 2012
Planned Number of Subjects		120
Nature of Investigation		Interventional
Study Design	Description of Trial Design	The AD and mild cognitive impairment (MCI), and cognitive intact healthy control (HC) subjects are studied. All subjects undergo cognitive testing, [11C]-PIB PET and [18F]-flutemetamol PET.
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	No
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	AD, MCI and HC subjects undergo cognitive testing, [11C]-PIB PET and [18F]-flutemetamol PET. Informed consent is obtained.
	Exclusion Criteria	Other degenerative disease
	Minimum Age	No limit
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		Alzheimer's disease, mild cognitive impairment (MCI), and cognitive intact healthy control (HC) subjects
Intervention(s)		Intervention type:DRUG Name of intervention:[18F]-flutemetamol Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:INTRAVENOUS BOLUS Dose per administration:185MBq Dosing frequency / Frequency of use:ONCE Planned duration of intervention:for 2 years Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:
Health Condition(s) Keyword
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Primary Outcome(s)		The primary endpoint is the efficacy of blinded visual assessments of 18F-flutemetamol scans in AD, MCI and HC subjects with and without PIB retention.
Secondary Outcome(s)		The clinical disease stages of AD are divided into three phases; pre-symptomatic AD, prodromal AD and AD dementia, with [18F]-flutemetamol PET image and cognitive function.

Primary Sponsor	Shizuo Hatashita
Secondary Sponsor

Sources of funding	private fund

Name of Ethics Committee
Address
TEL	+81-3-3263-4801
FAX	+81-3-3263-4802
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Jan. 11, 2012

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Secondary Study ID	JMA-IIA00124
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	Aug. 07, 2018	(this page)	Changes
1	April. 09, 2013	Detail

List of change history