UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049624 |
|---|---|
| Receipt number | R000056510 |
| Scientific Title | Blood-brain barrier function assessed with MRI in cognitive deficits in neurological disorders |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/07/28 10:49:34 |
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Basic information
Public title
Blood-brain barrier function assessed with MRI in cognitive deficits in neurological disorders
Acronym
Blood-brain barrier function assessed with MRI in cognitive deficits in neurological disorders
Scientific Title
Blood-brain barrier function assessed with MRI in cognitive deficits in neurological disorders
Scientific Title:Acronym
Blood-brain barrier function assessed with MRI in cognitive deficits in neurological disorders
Region
| Japan |
Condition
Condition
Alzheimer disease, Dementia with Lewy bodies, Parkinson disease, Parkinsonism related disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether blood-brain barrier dysfunction contributes to cognitive deficits in neurodegenerative diseases
Basic objectives2
Others
Basic objectives -Others
To clarify whether blood-brain barrier dysfunction contributes to cognitive deficits in neurodegenerative diseases
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
blood-brain barrier function
Key secondary outcomes
Evaluation of cognitive function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
dynamic contrast-enhanced magnetic resonance imaging
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Alzheimer disease, Dementia with Lewy bodies, Parkinson disease and Parkinsonism related disorders. Healthy volunteers.
Key exclusion criteria
Chronic and acute renal failure with eGFR less than 30 ml/min/1.73m2
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Nobukatsu |
| Middle name | |
| Last name | Sawamoto |
Organization
Kyoto University Hospital
Division name
Department of Neurology
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507
TEL
075-751-3771
neuroofc@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobukatsu |
| Middle name | |
| Last name | Sawamoto |
Organization
Kyoto University Hospital
Division name
Department of Neurology
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507
TEL
075-751-3771
Homepage URL
neuroofc@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2023 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
intervention study with minor invasion
Management information
Registered date
| 2022 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056510
