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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017558
Receipt No. 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

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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
Email 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
Email matsudah@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020348

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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