UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000020348