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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Mild cognitive impairment, preclinical AD | ||
Classification by specialty |
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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 |
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Interventions/Control_1 | Brain Positron Imaging by intravenous administration of 11C-labeled amyloid PET diagnostic drug | |
Interventions/Control_2 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | The University of Tokyo Hospital
Unit for Early and Exploratory Clinical Development |
Institute | |
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Funding Source | |
Organization | Brain/Minds project |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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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 |