UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055312 |
|---|---|
| Receipt number | R000063188 |
| Scientific Title | Imaging study of mitochondrial function in brain and whole body for aging and dementia spectrum |
| Date of disclosure of the study information | 2024/09/05 |
| Last modified on | 2025/03/12 11:27:56 |
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Basic information
Public title
Study of changes in mitochondrial function in brain and internal organs caused by aging and dementia with PET
Acronym
Mitochondrial function in aging and dementia
Scientific Title
Imaging study of mitochondrial function in brain and whole body for aging and dementia spectrum
Scientific Title:Acronym
Imaging study of mitochondrial function in aging and dementia
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Psychiatry | Radiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to reveal changes in mitochondrial function in brain and internal organs with aging and dementia spectrum by using PET with 18F-BCPP-EF.
Basic objectives2
Others
Basic objectives -Others
Pathophysiological study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in mitochondrial function in brain and internal organs due to aging and dementia
Key secondary outcomes
Correlations between clinical, hematological, and imaging data
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Blood sampling, intravenous PET tracer injection, CT imaging, and PET 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
(1) Individuals who are >= 20 years old and < 90 years old at the time of informed consent acquisition
(2) Individuals without past or current history of psychiatric disorder, neurological disorder, or lifestyle disease
(3) Individuals without smoking history
(4) Individuals without alcoholics
(5) Individuals not taking regular medicines
(6) Capability of written informed consent based on their own decision
Patients
(1) Individuals who are >= 50 years old and < 90 years old at the time of informed consent acquisition
(2) Mild cognitive impairment or Alzheimer's disease
(3) Individuals without diabetes mellitus
(4) Individuals not taking regular psychotropic medicine
(5) Individuals without smoking history
(6) Individuals without alcoholics
(7) Capability of written informed consent based on their own decision or a legally acceptable representative
Key exclusion criteria
(1) Healthy subjects who have participated in other nuclear medicine examinations as healthy volunteers within the past year
(2) Individuals with risk of MRI scan (individuals with pacemakers, brain clips, bolts, tattoos, art makeup, claustrophobia, etc.)
(3) Pregnant, possibly pregnant, or lactating women
(4) Individuals judged inappropriate as research subjects by the physician who is principal investigator or co-investigator for other reasons
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yasuomi |
| Middle name | |
| Last name | Ouchi |
Organization
Hamamatsu Medical Photonics Foundation
Division name
Hamamatsu Medical Imaging Center
Zip code
434-0041
Address
5000, Hirakuchi, Hamana-ku, Hamamatsu City, Shizuoka, Japan
TEL
053-584-6411
ouchi@hmp.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ohba |
Organization
Hamamatsu Photonics K.K.
Division name
Central Research Laboratory
Zip code
434-8601
Address
5000, Hirakuchi, Hamana-ku, Hamamatsu City, Shizuoka, Japan
TEL
053-586-7111
Homepage URL
h-ohba@crl.hpk.co.jp
Sponsor or person
Institute
Hamamatsu Medical Photonics Foundation
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Photonics K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu Medical Photonics Foundation
Address
5000, Hirakuchi, Hamana-ku, Hamamatsu City, Shizuoka, Japan
Tel
053-584-6411
takagi@hmp.or.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
| 2024 | Year | 09 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063188
