UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024541 |
|---|---|
| Receipt number | R000028226 |
| Scientific Title | Longitudinal assessment of accumulation of tau-imaging PET tracer [18F]THK-5351 |
| Date of disclosure of the study information | 2016/10/25 |
| Last modified on | 2020/10/27 13:31:48 |
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Basic information
Public title
Longitudinal assessment of accumulation of tau-imaging PET tracer [18F]THK-5351
Acronym
Longitudinal assessment of tau PET tracer [18F]THK-5351
Scientific Title
Longitudinal assessment of accumulation of tau-imaging PET tracer [18F]THK-5351
Scientific Title:Acronym
Longitudinal assessment of tau PET tracer [18F]THK-5351
Region
| Japan |
Condition
Condition
Alzheimer's disease, Mild cognitive impairment, healthy volunteers, Frontotemporal lobe degeneration, Progressive Supranuclear Palsy and Dementia with Lewy body.
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed at evaluating the sequential changes in the spatial distribution of tau PET tracer [18F]THK5351 and its association with cognitive decline in patients with Alzheimer's disease, mild cognitive decline, healthy volunteers and the other tauipathies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The annual change in the [18F]THK-5351 retention in the brain.
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 and [11C]PiB PET studies will be performed in the patients and healthy volunteers.
PET images of the brain will be acquired from 40 to 60 min after intravenous administration of 185 mBq [18F]THK-5351, and from 50 to 70 min after intravenous administration of 296 MBq [11C]PiB.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
probable AD (NINCDS-ADRDA Working Group)
Mild Cognitive Impairment (petersen's criteria)
Frontotemporal Lobar Degeneration (Neary's criteria)
Progressive Supranuclear Palsy (NINDS-SPSP International Workshop)
Dementia with Lewy Body (McKeith's criteria)
Healthy normal subjects without cognitive impairment
Key exclusion criteria
Subjects with neuropsychiatric diseases other than inclusion ariteria, subjects with severe cardiac abnormalities, and subjects with pacemaker or metal device in the body.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Tomita |
Organization
Tohoku University Hospital
Division name
Department of Geriatric Medicine and Neuroimaging
Zip code
9808575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7182
naoki.tomita.b1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Ishiki |
Organization
Tohoku University Hospital
Division name
Department of Geriatric Medicine and Neuroimaging
Zip code
9808575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7182
Homepage URL
aiko.ishiki.e1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board, Tohoku University
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
| 2016 | Year | 10 | 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
| 2016 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 24 | Day |
Last modified on
| 2020 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028226
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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