UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038947 |
|---|---|
| Receipt number | R000044411 |
| Scientific Title | The relationship between central glial activation and peripheral proinflammatory material of Alzheimer's disease mesured by PET-TSPO imaging |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2026/06/26 10:02:06 |
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Basic information
Public title
The relationship between central glial activation and peripheral proinflammatory material of Alzheimer's disease mesured by PET-TSPO imaging
Acronym
PET-TSPO imaging :central glial activation and peripheral proinflammatory material of Alzheimer's disease
Scientific Title
The relationship between central glial activation and peripheral proinflammatory material of Alzheimer's disease mesured by PET-TSPO imaging
Scientific Title:Acronym
PET-TSPO imaging :central glial activation and peripheral proinflammatory material of Alzheimer's disease
Region
| Japan |
Condition
Condition
Dementia of Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
By using PET imaging with [11C]DPA-713, we will measure the central glial activation in the patients with AD. We will investigate the relationship between central glial activation and the peripheral material related to the infllamation and glial acivation
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the central glial activation measured by PET with [11C]DPA-713 and the peripheral material related to the infllamation and glial acivation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Alzheimer`s disase patient whose symptoms fulfilled the clinical diagnostic criteria
Key exclusion criteria
The AD patients with medical history of
neurological and psychiatrical disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumihiko |
| Middle name | |
| Last name | Yasuno |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Psychiatry
Zip code
474-8511
Address
7-430 Morioka-cho Obu, Aichi
TEL
0562-46-2311
yasunof@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Fumihiko |
| Middle name | |
| Last name | Yasuno |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Psychiatry
Zip code
474-8511
Address
7-430 Morioka-cho Obu, Aichi
TEL
0562-46-2311
Homepage URL
yasunof@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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 for Geriatrics and Gerontology
Address
7-430 Morioka-cho
Tel
0562462311
yaday@ncgg.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
| 2020 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
ttps://www.ncgg.go.jp/ri/biobank/cooperation/kenkyu/1276-5.html
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37648003/
Number of participants that the trial has enrolled
17
Results
Translocator protein-PET imaging of glial activation is a stronger predictor of AD clinical progression than the amount of amyloid/tau pathology measured using CSF concentrations. Glial activation is the primary cause of tau-induced neuronal toxicity and cognitive deterioration, thereby highlighting the potential of blocking maladaptive microglial responses as a therapeutic strategy for AD treatment.
Results date posted
| 2026 | Year | 06 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with Alzheimer's disease (AD) who meet the eligibility criteria based on clinical diagnosis and whose blood samples and clinical information are registered and stored in our center's biobank
Participant flow
In a cohort of patients with Alzheimer disease whose blood samples and clinical data are registered and stored in our center's biobank, we used [11C]DPA-713 PET to quantitatively assess in vivo the inflammatory responses occurring in the brain during the degenerative process. Concurrently, we conducted a quantitative analysis of the relationship between the dynamic changes in proteins, cytokines, and inflammation-associated cells in cerebrospinal fluid and peripheral blood induced by inflammation, and clinical symptoms--primarily those related to cognition and psychobehavioral aspects of dementia.
Adverse events
PET scans involve radiation exposure, but the amount is not significant enough to affect the human body.
Regarding arterial blood sampling during a PET scan, there is a risk of arterial occlusion or nerve damage, but the likelihood is extremely low.
There is a possibility of side effects such as allergic reactions to local anesthetics or anticoagulants, a decrease in platelet count, or bleeding; however, these are all extremely rare.
With a cerebrospinal fluid (CSF) test, there is a risk of infection when the needle is inserted, as well as the risk of nerve damage leading to persistent numbness or bleeding that compresses the spinal nerves; however, these are all rare.
Regarding the use of samples and information collected by the National Center for Geriatrics and Gerontology Biobank, sufficient consideration is given to the protection of privacy; therefore, no new adverse effects or risks are anticipated.
Outcome measures
Using [11C]DPA-713-based PET, we will quantitatively assess in vivo the inflammatory response in the brain that occurs during the degenerative process. At the same time, we will conduct a quantitative analysis of the relationship between the dynamic changes in cerebrospinal fluid and peripheral blood--including proteins, cytokines, and inflammatory cells--induced by inflammation, and clinical symptoms of dementia, with a focus on cognitive and psychobehavioral aspects.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now the research is progressing according to the research protocol.
Management information
Registered date
| 2019 | Year | 12 | Month | 21 | Day |
Last modified on
| 2026 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044411
