UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039675 |
|---|---|
| Receipt number | R000045250 |
| Scientific Title | MRI study to elucidate the mechanism of cognitive dysfunction |
| Date of disclosure of the study information | 2020/03/03 |
| Last modified on | 2025/03/07 22:47:19 |
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Basic information
Public title
MRI study to elucidate the mechanism of cognitive dysfunction
Acronym
MRI study to elucidate the mechanism of cognitive dysfunction
Scientific Title
MRI study to elucidate the mechanism of cognitive dysfunction
Scientific Title:Acronym
MRI study to elucidate the mechanism of cognitive dysfunction
Region
| Japan |
Condition
Condition
Healthy subjects, mild cognitive impairment
Classification by specialty
| Neurology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aiming to elucidate the mechanism of cognitive dysfunction using magnetic resonance imaging (MRI) in patients with mild cognitive impairment and healthy subjects
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The purpose of this study is to compare functional MRI images during memory tasks between healthy subjects and mild cognitive impairment. Investigate the relationship between these findings and cognitive function test results
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The subject fully understands the contents of the research and written consent is obtained from the subject.
2. In this research, we have newly registered the healthy volunteers and mild cognitive impairment (MCI) who have no audio-visual disorder, normal writing ability and Japanese as their mother tongue.
Key exclusion criteria
1. There is a problem to take a MRI imaging due to pacemaker, aneurysm clip, artificial valve, cochlear implant or other magnetic or electrically conductive metal, or claustrophobia.
2. If you have psychiatric symptoms, excitability, behavior abnormalities that make it difficult to follow the protocol within the past 1 year.
3. When suffering from severe systemic disease or unstable disease.
4. It is judged by the attending physician not to be appropriate.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nariko |
| Middle name | |
| Last name | Katayama |
Organization
Keio University
Division name
School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
+81-3-3353-1211
narikoktym@keio.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Tabuchi |
Organization
Keio University
Division name
School of Medicine
Zip code
160/8582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
+81-3-3353-1211
Homepage URL
tabuchi@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Keio University, School of Medicine
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
Tel
+81-3-3353-1211
tabuchi@keio.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
| 2020 | Year | 03 | Month | 03 | 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 | 02 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 10 | 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
Case control study
Management information
Registered date
| 2020 | Year | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045250
