UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039724 |
|---|---|
| Receipt number | R000045306 |
| Scientific Title | An observational study for patients with cognitive impairments using an advanced MRI which can detect blood-brain barrier functions |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2024/03/09 23:58:36 |
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Basic information
Public title
An observational study for patients with cognitive impairments using an advanced MRI which can detect blood-brain barrier dysfunctions
Acronym
BBB dysfunctions in patients with cognitive impairments
Scientific Title
An observational study for patients with cognitive impairments using an advanced MRI which can detect blood-brain barrier functions
Scientific Title:Acronym
BBB dysfunctions in patients with cognitive impairments
Region
| Japan |
Condition
Condition
Patients with cognitive impairments
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine blood-brain barrier dysfunctions
Basic objectives2
Others
Basic objectives -Others
Quantitative susceptibility mapping, amyloid PET, Neuropsychological assessments
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood-brain barrier dysfunctions
Key secondary outcomes
Quantitative susceptibility mapping, amyloid PET, Neuropsychological assessments
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
0 < Clinical dementia rating < 3
Key exclusion criteria
Inability for MR imaging
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Uchida |
| Middle name | Kato |
| Last name | Yuto |
Organization
Nagoya City University
Division name
Neurology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-ku, Nagoya
TEL
0528538094
uchidayuto0720@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Nagoya City University
Division name
Neurology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-ku, Nagoya
TEL
0528538094
Homepage URL
uchidayuto0720@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI19K17148
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
Clinical research management center
Address
1 Kawasumi, Mizuho-ku, Nagoya
Tel
052-858-7215
clinical_research@med.nagoya-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
60-16-0150
Org. issuing International ID_1
Nagoya City University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | 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
| 2020 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
NA
Management information
Registered date
| 2020 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045306
