UMIN-CTR Clinical Trial

Basic information
Public title	effectiveness of neuroimgaing in the early diagnosis of neurodegeneration
Acronym	effectiveness of neuroimgaing in the early diagnosis of neurodegeneration
Scientific Title	effectiveness of neuroimgaing in the early diagnosis of neurodegeneration
Scientific Title:Acronym	effectiveness of neuroimgaing in the early diagnosis of neurodegeneration
Region	Japan

Condition
Condition	neurodegeneration
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	to reveal the effectiveness of neuroimaging in early diagnosis of neurodegeneration
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	features of neuroimaging in patients with early stage of neurodegeneration
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	resting functional imaging
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are suspected of neurodegenerative disease or who are diagnosed as neurodegenerative diseases. Specifically, it includes Alzheimer's dementia, Parkinson's disease, Lewy body dementia, Parkinson's disease accompanied by dementia, Progressive supranuclear palsy, Corticobasal nuclear degeneration, Multiple system atrophy, Amyotrophic lateral sclerosis and Frontotemporal dementia
Key exclusion criteria	Underage. Patients who are complicated with cerebral organic disease. Patints who merge substance-related disorders (drug dependence etc.). Patients who have complications of serious diseases, or patients who have a history of these diseases. Patient with claustrophobia. Patients who has pacemaker, body metal, tattoo. Patients who may be pregnant or who are breastfeeding. In addition, patients judged by a doctor to be inappropriate as subjects.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Gen Middle name Last name Sobue
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Neurodegenerative and dementia control research
Zip code	466-8560
Address	65, Tsurumaicho, Showaku, Nagoya
TEL	052-744-2391
Email	neurology@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Aya Middle name Last name Ogura
Organization	Nagoya University Graduate School of Medicine
Division name	Neurology
Zip code	466-8560
Address	65, Tsurumaicho, Showaku, Nagoya
TEL	052-744-2391
Homepage URL
Email	neurology@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya Univercity
Address	65, Tsurumaicho, Showaku, Nagoya
Tel	052-744-2061
Email	ethics@med.nagoya-u.ac.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	2017 Year 11 Month 15 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	34
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	2016 Year 11 Month 14 Day
Date of IRB	2016 Year 11 Month 14 Day
Anticipated trial start date	2016 Year 11 Month 14 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 22 Day
Last modified on	2019 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027334