UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017558 |
|---|---|
| Receipt number | R000020348 |
| Scientific Title | A study on neurocircuitry abnormalities at the very early stage of Alzheimer's disease |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2020/05/18 14:06:01 |
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Basic information
Public title
A study on neurocircuitry abnormalities at the very early stage of Alzheimer's disease
Acronym
neurocircuitry abnormalities in Alzheimer's disease
Scientific Title
A study on neurocircuitry abnormalities at the very early stage of Alzheimer's disease
Scientific Title:Acronym
neurocircuitry abnormalities in Alzheimer's disease
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect neurocircuitry abnormalities in healthy voluteers and mild cognitive impairments with positive amyloid PET findings
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of functional connectivity between amyloid positive and negative subjects with normal cognition and mild cognitive impairment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Diagnosis using amyloid PET
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
Amyloid PET negative healthy volunteers
Amyloid PET positive healthy volunteers
Amyloid PET negative patients with mild cognitive impariment
Amyloid PET positive patients with mild cognitive impariment
Key exclusion criteria
other neurodegenerative disease patients than Alzheimer's disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsuda |
Organization
National Center of Neurology and Psychiatry
Division name
Integrative Brain Imaging Center
Zip code
187-8551
Address
4-1-1, Ogawahigashi, Kodaira 187-8551
TEL
0423412712
matsudah@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsuda |
Organization
1954
Division name
Integrative Brain Imaging Center
Zip code
187-8551
Address
4-1-1, Ogawahigashi, Kodaira, Tokyo 187-8551
TEL
0423412712
Homepage URL
matsudah@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
A project for full elucidation of brain function network by innovative technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry, ethical committee
Address
4-1-1, Ogawahigashi, Kodaira
Tel
0423412711
rinri-jimu@ncnp.go.jp
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 | 05 | Month | 14 | 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 | 03 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 13 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 14 | Day |
Last modified on
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020348
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
