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 | 2026/01/03 09:35:05 |
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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
5
Results
Five elderly patients with mild language dysfunction and a degenerative temporal pole lesion underwent FDG-PET, amyloid-PET and tau-PET. Four of them presented PET findings inconsistent with Alzheimer process as the primary pathology. Word expression and comprehension of atypical meaning in idiomatic context were impaired while comprehension of abstract words and relationship of semantic representation were preserved, the former of which was considered vulnerable at the early stage of semantic dysfunction.
Results date posted
| 2026 | Year | 01 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All subjects presented an atrophy of the left temporal pole observed by the brain magnetic resonance imaging (MRI), a dominant hypoperfusion in the left temporal pole revealed by N-isopropyl-p-[123I]iodoamphetamine-single photon emission tomography (IMP-SPECT), the score of 22 or more on Mini Mental State Examination and the score of verbal memory lower than visual memory by 15 points or more on the Wechsler Memory Scale-Revised.
Participant flow
Five subjects with ages between 72 to 86 years old were registered during the five-year study period. All of them underwent three positron emission tomography (PET) scans of brain using 18F-fluorodeoxyglucose (FDG) for glucose metabolism, 18F-florbetapir for amyloid, and 18F-MK-6240 for tau.
They also underwent psychological tests, including Western Aphasia Battery, The Lexical Profile Assessment for Aphasia, The Pyramid and Palm Tree Test, Japanese Adult Reading Test, Token Test (Japanese Ver), The Stereotypy Rating Inventory and Frontal Behavioral Inventory. The task of word meaning aphasia, the task of completion phenomenon of proverbs by Tanabe et al. (1992), the task of idiomatic phrases with body part names and the test for comprehension of homophones by Hashimoto et al. (2015) were performed for all the patients as well.
Adverse events
None.
Outcome measures
FDG-PET revealed selective hypometabolism at the left frontal pole of all subjects. One subject (No.5) also showed hypometabolism in the entire left temporal cortex extending to the parietal area. Three subjects including No.5 were amyloid positive based on the image interpretation criteria, whereas none presented selective and characteristic pathological tau accumulation in the left temporal pole to the anterior temporal cortex. Subject No.5 showed extensive tau accumulation in the entire temporal cortex, as well as in the parietal and frontal cortex (progressed Alzheimer pattern). Therefore, the functional decline of the temporal pole in the other four cases including the two amyloid positive ones, as confirmed by FDG-PET and neuropsychological tests, were not likely to be attributed to amyloid pathology as the primary cause. These findings suggest that the neuropathological basis of left frontal pole dysfunction of subjects without perisylvian or parietal lesions and without impairment of verbatim repetition is not likely Alzheimer disease. Neurodegenerative disorder starting in temporal pole often develops to semantic dementia (SD), in which type C of TAR DNA-binding protein of 43 kDa (TDP-43) constitutes the primary pathology in most cases. The PET findings in the 4 subjects of the present study seem to be consistent with such SD pathology, although our patients are atypical of SD in terms of age and clinical manifestations, which may not necessarily allow speculating exactly the same pathological process as SD.
In the test of Lexical Processing in Aphasia, all five subjects showed good result of lexical decision task, indicating their preserved lexicons. But the scores of the noun expression test and verb expression test declined in all, displaying a clinical feature of word finding difficulty or anomia. The Standardized Comprehension Test of Abstract Words revealed a low score in one of five subjects, but not the others. No subjects marked deficit scores on Pyramid and Palm Tree Test. No subject presented surface dyslexia on the task of word meaning aphasia by Tanabe et al. Impaired comprehension of proverbs and idiomatic phrases with a word of a body part were the most sensitive tests.
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 05 | Month | 31 | Day |
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
| 2026 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053090
