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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046538
Receipt No. 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 2022/01/05

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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. Twelve 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
Email 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
Email michio_senda@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

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
Email 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
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 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
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 05 Day
Last modified on
2022 Year 01 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053090

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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