UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046094 |
|---|---|
| Receipt number | 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 | 2025/05/23 09:18:01 |
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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
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
okazawa@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
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
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
福井大学
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
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
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052617
