UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043737 |
|---|---|
| Receipt number | R000032344 |
| Scientific Title | Clinical evaluation of tau-imaging PET tracer [18F]THK-5351 in dementia |
| Date of disclosure of the study information | 2021/03/25 |
| Last modified on | 2022/03/11 17:42:33 |
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Basic information
Public title
Clinical evaluation of tau-imaging PET tracer [18F]THK-5351 in dementia
Acronym
Clinical evaluation of [18F]THK-5351 in dementia
Scientific Title
Clinical evaluation of tau-imaging PET tracer [18F]THK-5351 in dementia
Scientific Title:Acronym
Clinical evaluation of [18F]THK-5351 in dementia
Region
| Japan |
Condition
Condition
mild cognitive impairment, Alzheimer's disease, corticobasal degeneration, progressive supranuclear palsy, frontotemporal dementia, dementia with Lewy bodies and Parkinson's disease and healthy volunteers
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Radiology | Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Differential diagnosis and pathophysiological investigation of dementia using tau-imaging PET tracer [18F]THK-5351
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution of tau-imaging PET tracer [18F]THK-5351
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
[18F]THK-5351 PET or PET/CT studies will be performed in the patients and healthy volunteers. PET images of the brain will be acquired for 90 min after intravenous injection of 2-5 MBq/kg [18F]THK-5351.
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
1) mild cognitive impairment, Alzheimer's disease, corticobasal degeneration, progressive supranuclear palsy, frontotemporal dementia, dementia with Lewy bodies and Parkinson's disease
2) 20 years of age or older at the time of obtaining consent
Key exclusion criteria
1) Pregnant, possibly pregnant or lactating women
2) Subject who is facing a life crisis
3) Subject who was judged by the investigator to be inappropriate as a participant in this study
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Nishiyama |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Radiology
Zip code
7610793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun Kagawa
TEL
087-898-5111
nisiyosi@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Yamamoto |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Radiology
Zip code
7610793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun Kagawa
TEL
087-898-5111
Homepage URL
yuka@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa University
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel
0878985111
yuka@med.kagawa-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 25 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2027 | 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
| 2021 | Year | 03 | Month | 25 | Day |
Last modified on
| 2022 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032344
