UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036956 |
|---|---|
| Receipt number | R000042104 |
| Scientific Title | A tau PET study with 18F-THK5351 on neurodegenerative disorders patients. |
| Date of disclosure of the study information | 2019/06/04 |
| Last modified on | 2025/02/28 16:19:51 |
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Basic information
Public title
A tau PET study with 18F-THK5351 on neurodegenerative disorders patients.
Acronym
A tau PET study with 18F-THK5351 on neurodegenerative disorders patients.
Scientific Title
A tau PET study with 18F-THK5351 on neurodegenerative disorders patients.
Scientific Title:Acronym
A tau PET study with 18F-THK5351 on neurodegenerative disorders patients.
Region
| Japan |
Condition
Condition
Patients who are suspected neurodegenerative disorders including Alzheimer disease, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, frontotemporal lobe degeneration, Parkinson's disease, dementia with Lewy bodies, and others including possibly tau positive, negative, and inconstant disorders.
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To disclose heterogeneity of tau and amyloid deposit among brains of various neurodegenerative disorders patients by using 18F-THK5351 and 11C-PiB PET.
Basic objectives2
Others
Basic objectives -Others
pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the distribution of tau deposit among disorders manifesting parkinsonism or dementia.
Key secondary outcomes
Relationship between clinical pictures and distributions of tau and amyloid deposit.
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
| Device,equipment |
Interventions/Control_1
18F-THK5351 and 11C-PiB PET
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have intention to participate in the PET study and are suspected having neurodegenerative disorders.
Key exclusion criteria
Patients having history of seizure, alcoholism, or any kind of drug dependency.
Patients recognized to be inappropriate by anyone of attending physicians or study staffs.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Horimoto |
Organization
Nagoya City Rehabilitation Agency
Division name
Department of Neurology
Zip code
4678622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
holly@nagoya-rehab.or.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Horimoto |
Organization
Nagoya City Rehabilitation Agency
Division name
Department of Neurology
Zip code
4678622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
holly@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Rehabilitation Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City Rehabilitation Agency
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel
052-835-3811
soumubu@nagoya-rehab.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
名古屋市総合リハビリテーション事業団(愛知県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 04 | 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
11
Results
In a study of 11 cases with progressive aphasia, THK5351 showed unevenly distributed areas of accumulation suggestive of a causative lesion. By contrast with amyloid PET, we were able to distinguish cases in which Alzheimer's disease was suggested as the background pathology, but the clinical presentation of the patients was not uniform.
Results date posted
| 2025 | Year | 02 | Month | 28 | Day |
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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 11 | 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
| 2019 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042104
