UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024215 |
|---|---|
| Receipt number | R000025813 |
| Scientific Title | The study on pathophysiology of neurocognitive disorders by 18F-THK5351 PET |
| Date of disclosure of the study information | 2016/09/29 |
| Last modified on | 2022/04/07 08:18:29 |
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Basic information
Public title
The study on pathophysiology of neurocognitive disorders by 18F-THK5351 PET
Acronym
Tau PET for early dementia
Scientific Title
The study on pathophysiology of neurocognitive disorders by 18F-THK5351 PET
Scientific Title:Acronym
Tau PET for early dementia
Region
| Japan |
Condition
Condition
mild cognitive impairment
Alzheimer disease
Dementia with Lewy bodies
Classification by specialty
| Neurology | Geriatrics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the tau accumulation in Alzheimer and other neurocognitive disorders brain and to clarify the relationship between clinical symptoms of the diseases and tau depositions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of tau accumulation and distribution in the disease brain.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Tau PET, MRI, Neuropsychological test
Interventions/Control_2
Tau PET, MRI, Neuropsychological test
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
| 30 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Disease group:
Subjects who experienced brain MRI and neuropsychological test and suspected to be dementia or MCI.
Provide informed consent and adhere to the protocol.
Control group:
Subjects without past or current history of cognitive dysfunction and with normal findings by neuropsychological test.
Provide informed consent and adhere to the protocol.
Key exclusion criteria
With past history of brain disease or traumatic brain injury
With severe lifestyle-related disease
With cancer or cardiac disease
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Ishii |
Organization
Kindai University Faculty of Medicine
Division name
Neurocognitive Disorders Ceneter
Zip code
589-8511
Address
377-2 Ohnohigashi, Osakasayama, Osaka
TEL
072-366-0221
ishii@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Kazunari |
| Middle name | |
| Last name | Ishii |
Organization
Kindai University Faculty of Medicine
Division name
Neurocognitive Disorders Ceneter
Zip code
589-8511
Address
377-2 Ohnohigashi, Osakasayama, Osaka
TEL
072-366-0221
Homepage URL
ishii@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kindai University Faculty of Medicine
Department of Radiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine
Address
377-2 Ohnohigashi
Tel
072-366-0221
zizen@med.kindai.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 | 09 | Month | 29 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | 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
| 2016 | Year | 09 | Month | 29 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025813
