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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046094
Receipt No. R000052617
Scientific Title Molecular imaging for pathophysiologic evaluation of dementia-related neurodegenerative diseases
Date of disclosure of the study information 2021/11/17
Last modified on 2021/11/17

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Basic information
Public title Brain imaging of dementia
Acronym Brain imaging of dementia
Scientific Title Molecular imaging for pathophysiologic evaluation of dementia-related neurodegenerative diseases
Scientific Title:Acronym Molecular imaging of dementia
Region
Japan

Condition
Condition Patients with dementia and healthy subjects of the same age group who meet all the criteria.
Classification by specialty
Neurology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By confirming the progressing process of protein degeneration and aggregation using molecular imaging methods, we will focus on the relationship between the pathogenesis of dementia and oxidative stress in the brain to elucidate the causes of neurodegeneration and the pathogenesis of dementia, leading to early treatment and effective prevention.
Basic objectives2 Others
Basic objectives -Others We will develop effecttive imaging methods useful for elucidating the mechanisms of dementia by combining multivariate analysis and brain function mapping analysis from dementia stages and healthy cohorts.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will compare amyloid, tau, and oxidative stress images in patients with dementia and healthy controls to determine the specific distribution and pattern of PET ligands in neurodegenerative diseases, and to evaluate whether PET/MRI is a useful method for assessing the pathophysiology.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 This is an observational study, but imaging results will open to patients.
Interventions/Control_2 Controls continue self-followup. Imaging results may be opened to subjects if they are positive.
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
45 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with MCI or early-stage dementia whose written consent has been freely given by the patient, and healthy people who participate of their own free will.
Key exclusion criteria 1. Patients with complications of organic brain diseases other than the target disease
2. Patients with complications from serious diseases
3. Patients with claustrophobia
4. Patients with pacemakers or internal metal (brain clips, bolts, etc.)
5. Patients with tattoos (including artistic makeup)
6. Patients who are pregnant, may become pregnant, or are breastfeeding
7. Other patients who are judged by the principal investigator or sub-investigator to be unsuitable as subjects.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Hidehiko
Middle name
Last name Okazawa
Organization University of Fukui
Division name Biomedical Imaging Research Center
Zip code 910-1193
Address 23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui
TEL 0776-61-8491
Email okazawa@u-fukui.ac.jp

Public contact
Name of contact person
1st name Hidehiko
Middle name
Last name Okazawa
Organization University of Fukui
Division name Biomedical Imaging Research Center
Zip code 910-1193
Address 23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui
TEL 0776-61-8491
Homepage URL
Email okazawa@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization University of Fukui
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee of the University of Fukui Hospital
Address 23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui
Tel 0776-61-3111
Email rinsho-rinri@ml.u-fukui.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
2021 Year 11 Month 17 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 Preinitiation
Date of protocol fixation
2021 Year 09 Month 03 Day
Date of IRB
2021 Year 09 Month 08 Day
Anticipated trial start date
2022 Year 01 Month 16 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 17 Day
Last modified on
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052617

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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