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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000017505
Receipt No. R000020292
Scientific Title Brain Mapping by Integrated Neurotechnologies for Disease Studies: Human Brain Aging Imaging Study
Date of disclosure of the study information 2015/09/01
Last modified on 2019/05/14

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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
Category of Funding Organization
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
Registered date File name

Research case data
Registered date File name


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