UMIN-CTR Clinical Trial

Basic information
Public title	Brain Mapping by Integrated Neurotechnologies for Disease Studies: Human Brain Aging Imaging Study
Acronym	Brain/Minds Aging Imaging Study
Scientific Title	Brain Mapping by Integrated Neurotechnologies for Disease Studies: Human Brain Aging Imaging Study
Scientific Title:Acronym	Brain/Minds Aging Imaging Study
Region	Japan

Condition
Condition	Mild cognitive impairment, preclinical AD
Classification by specialty	Neurology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To apply functional MRI methodologies to the very early stage of Alzheimer disease, MRI imaging data including structural MRI, resting state functional MRI, diffusion tensor imaging and arterial spin labeling will be acquired in MCI or preclinical AD individuals.
Basic objectives2	Others
Basic objectives -Others	Compare the MRI data with amyloid PET images and cognitive data.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Volumetric differences in the hippocampus and other areas in cognitive normal and MCI Micro volumetric analysis of subregions of hippocampus and other medial temporal areas in cognitive normal and MCI Differences in cerebral blood flow using ASL in cognitive normal and MCI Differences in functional connectivity using rsfMRI in cognitive normal and MCI Differences in DTI parameters in cognitive normal and MCI Differences in brain volume in hippocampal and other areas in amyloid positive and negative individuals Differences in volume of subregions of hippocampus and other medial temporal areas in amyloid positive and negative individuals Differences in ASL and rsfMRI parameters in amyloid positive and negative individuals Differences in DTI parameters in amyloid positive and negative individuals
Key secondary outcomes

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Brain Positron Imaging by intravenous administration of 11C-labeled amyloid PET diagnostic drug
Interventions/Control_2
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	60 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Cognitive normal aged individual with CDR score 0 or MCI with CDR score 0.5 (memory box >= 0.5); amyloid PET positive cognitive normal is categorized as preclinical AD and those negative as normal aged. A study partner is available Age 60-90 MRI eligible Other dementing illness is not diagnosed. No past history of intracranial diseases.
Key exclusion criteria	No past history of major depression or bipolar disorder, schizophrenia, alcoholism or drug addiction. CT or MRI findings indicative of cerebrovascular disease or ischemic changes that are causative for cognitive disorders. Individuals who are continuously taking drugs affecting cognitive functions. Individuals with unstable disease states that may hamper continuation of the study Individuals who are participating in other clinical study including CDR, WMS-R, logical memory or MMSE upon enrollment
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Iwatsubo
Organization	The University of Tokyo Hospital
Division name	Unit for Early and Exploratory Clinical Development
Zip code
Address	7-3-1 hongo Bunkyoku Tokyo
TEL	0358413541
Email	iwatsubo@m.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazushi Suzuki
Organization	The University of Tokyo Hospital
Division name	Unit for Early and Exploratory Clinical Development
Zip code
Address	7-3-1 Hongo Bunkyoku Tokyo
TEL	0358415646
Homepage URL
Email	kazusuzuki-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital Unit for Early and Exploratory Clinical Development
Institute
Department

Funding Source
Organization	Brain/Minds project
Organization
Division
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Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 03 Day
Date of IRB	2015 Year 02 Month 19 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 05 Month 11 Day
Last modified on	2019 Year 05 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020292

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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