UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057139 |
|---|---|
| Receipt number | R000065314 |
| Scientific Title | Pathophysiology of Parkinson's disease and related disorders using THK5351 PET |
| Date of disclosure of the study information | 2025/02/26 |
| Last modified on | 2025/02/26 16:46:26 |
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Basic information
Public title
Pathophysiology of Parkinson's disease and related disorders using THK5351 PET
Acronym
Pathophysiology of Parkinson's disease and related disorders using THK5351 PET
Scientific Title
Pathophysiology of Parkinson's disease and related disorders using THK5351 PET
Scientific Title:Acronym
Pathophysiology of Parkinson's disease and related disorders using THK5351 PET
Region
| Japan |
Condition
Condition
Parkinson's disease and related disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Neurodegeneration is observed in Parkinson's disease and related disorders, but its distribution is thought to be different.THK5351 is a PET probe developed to target tau and neurofibrillary tangles, but because it has cross-activities with MAO-B, it has been shown to depict neurodegeneration and gliosis along with neurofibrillary tangles. It has been shown that it can depict neurodegeneration and gliosis as well as neurofibrillary tangles. If the distribution of lesions in Parkinson's disease and related diseases can be delineated using this probe, it will be very useful in elucidating the pathophysiology of each disease.
Basic objectives2
Others
Basic objectives -Others
elucidation of pathological conditions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SUVR
Key secondary outcomes
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
THK5351 administered intravenously
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are suspected of having Parkinson's disease, multiple system atrophy, progressive supranuclear palsy, or other Parkinson's disease-related diseases among those who visit the Nagoya City Rehabilitation Center Hospital will be selected, and those who agree and consent to PET imaging for research purposes will be included.
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
30
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
| 2025 | Year | 02 | Month | 26 | 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
79
Results
In a study of only 79 cases before the shutdown, high SUVR to the middle and middle cerebral peduncles was observed in 3 cases of multiple system atrophy. In addition, six patients with progressive nucleus tractus palsy had a high midbrain-bridge ratio of SUVR. None of these findings were seen in other diseases, including Parkinson's disease, and had high differential power.
Results date posted
| 2025 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
SUVR
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065314
