UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017505 |
|---|---|
| Receipt number | 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 10:11:24 |
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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
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
kazusuzuki-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Unit for Early and Exploratory Clinical Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020292
