UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046538 |
|---|---|
| Receipt number | R000053090 |
| Scientific Title | Significance of amyloid and tau deposition in mild verbal cognitive impairment with left temporal lobe degeneration |
| Date of disclosure of the study information | 2022/01/05 |
| Last modified on | 2024/07/08 07:51:17 |
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Basic information
Public title
Pathophysiological study on mild verbal cognitive impairment with left temporal lobe degeneration using PET imaging of amyloid and tau deposition
Acronym
TEMPOL study
Scientific Title
Significance of amyloid and tau deposition in mild verbal cognitive impairment with left temporal lobe degeneration
Scientific Title:Acronym
TEMPOL study
Region
| Japan |
Condition
Condition
primary progressive aphasia
Classification by specialty
| Neurology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore pathophysiology of primary progressive aphasia with left temporal degeneration based on the PET images of amyloid, tau and glucose metabolism and their relationship with language and semantic cognitive dysfunction.
Basic objectives2
Others
Basic objectives -Others
pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
presence/absence of amyloid deposition evaluated by PET
Key secondary outcomes
PET images of amyloid, tau and glucose metabolism.
Language and semantic cognitive function.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Brain amyloid PET with a 20min scan starting 50min post-injection of 370MBq of [18F]florbetapir. Brain tau PET with a 30min scan starting 90min post-injection of 185MBq of [18F]MK-6240. Brain FDG-PET with a 30min scan starting 30min post-injection of 185MBq of [18F]FDG. All PET scans are performed once within 6 months of informed consent.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Hypoperfusion or hypometabolism localized in the left temporal pole revealed by SPECT or PET. 2. Atrophy of the left temporal pole revealed by MRI. 3. Right handed. 4. Linguistic memory more impaired than visual memory in WMSR. 5. Twenty or higher score in MMSE. 6. Able to undergo all the neuropsychological tests of this study. 7. Nine or more years of education.
Key exclusion criteria
1. Suspected of vascular dementia. 2. Cognitive impairment by suspected causes other than neurodegenerative disorders. 3. Suspected of psychiatric disorders such as schizophrenia and depression. 4. Unable to lie on bed for 60min. 5. Extreme claustrophobia. 6. Unable to undergo MRI scan. 7. Anticipatorily unable to undergo all the psychological tests of this study. 8. Possibility of pregnancy. 9. No capacity to consent, for example, due to dementia. 10. Inappropriate for enrollment as determined by principal investigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Senda |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Molecular Imaging Research
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-304-5212
michio_senda@kcho.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Senda |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Molecular Imaging Research
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-304-5212
Homepage URL
michio_senda@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research by 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
Kobe Gakuin University
Name of secondary funder(s)
Kobe Gakuin University
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital Ethics Committee
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
Tel
078-302-5176
rinken@kcho.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
神戸市立医療センター中央市民病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | 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
4
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Protocol was amended on Oct 23, 2023, which was approved on Dec 7, 2023.
Management information
Registered date
| 2022 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053090
