UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Early diagnosis of Alzheimer's disease using resting-state fMRI
Title of the study (Brief title)	Resting-state fMRI in Alzheimer's disease
Region	Japan

Condition
Condition	Alzheimer'd disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the usefulness of re-fMRI in Alzheimer's disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	regional brain function measured by rs-fMRI
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Oral administration of 75g glucose
Interventions/Control_2	nothing administgration
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	AD patients 1. The subjects who have intention to participate in this study, and signed informed consent. 2. Male and female subjects of >=60 and <90 years, old. Healthy sujbects 1. The subjects who have intention to participate in this study, and signed informed consent. 2. Male and female subjects of >=20 and <90 years, old.
Key exclusion criteria	1. The subjects with a history of brain diseases, excluding than cerebellar diseases. 2. The subjects who are prescribed a medication for the central nervous system. 3. The subject who have chronic dysfunction in the organs. 4. Pregnant or woman who has a chance of pregnant. 5. The subjects who were judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size	40

Research contact person
Name of lead principal investigator	Kenji Ishibashi
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Address	35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Email	ishibashi@pet.tmig.or.jp

Public contact
Name of contact person	Hiroko Sato
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Address	35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Homepage URL
Email	sato@pet.tmig.or.jp

Sponsor
Institute	Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Institute of Gerontology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 07 Day
Last modified on	2017 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026101