Unique ID issued by UMIN | UMIN000030436 |
---|---|
Receipt number | R000034643 |
Scientific Title | Examination of predicting factor of cognitive decline |
Date of disclosure of the study information | 2018/01/01 |
Last modified on | 2019/12/19 16:47:03 |
Examination of predicting factor of cognitive decline
Study of predicting factor of cognitive decline
Examination of predicting factor of cognitive decline
Study of predicting factor of cognitive decline
Japan |
Diabetes Mellitus, traumatic brain injury, depression, mild cognitive impairment
Endocrinology and Metabolism | Neurology | Geriatrics |
Psychiatry |
Others
NO
To evaluate the predictive factor of the cognitive decline in each diseases
Efficacy
Exploratory
Pragmatic
Not applicable
examination at the initial evaluation:
signal of [18F]flrobetapir
examination at the initial evaluation, 1 year evaluation, 2 year evaluation:
cognitive function
blood test
urine test
clinical symptoms
diagnosis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Prevention
Other |
Initial evaluation:
[18F]flrobetapir PET (370MBq), MRI, Neuropsychological examination, blood test, urine test
1st year evaluation:
Neuropsychological examination, blood test, urine test
2nd year evaluation:
Neuropsychological examination, blood test, urine test
20 | years-old | <= |
90 | years-old | > |
Male and Female
Subjects (20 y.o. <= age <90 y.o.) who have the ability to provide informed consent and adhere to the protocol.
Diabetes mellitus:
- Subjects who meet the critera of diabetes mellitus on the Japan Diabetes Society without past history of traumatic brain injury and major depressive disorder
Traumatic brain in jury:
Subjects with past history of traumatic brain injury, without past history of diabetes mellitus and major depressive disorder
Major depressive disorder:
- Subject who meet the diagnostic criteria of depressive episode on International classification of Diseases 10th revision
Mild cognitive impairment:
- Subject who had subjective and objective cognitive impairment without past history of diabetes mellitus, traumatic brain injury
- With past or current history of serious medical illness
- Subject who cannot undergo an MRI
- With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- Subjects who has possibility of pregnancy or is breast-feeding
- Subjects who has been exposed to radiation by job-related exposure or therapy in one year exceeding 15mSv
- Subjects who received contrast or radioactive agent within two days of the examination.
- Subjects who scheduled receiving contrast or radioactive agent the day after the examination.
- Subjects who are judged as not suitable for participation in this study
140
1st name | Yoshiro |
Middle name | |
Last name | Okubo |
Nippon Medical School
Department of Neuropsychiatry
113-8602
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
03-3822-2131
okubo-y@nms.ac.jp
1st name | Amane |
Middle name | |
Last name | Tateno |
Nippon Medical School
Department of Neuropsychiatry
113-8602
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
03-3822-2131
amtateno@nms.ac.jp
Nippon Medical School
MEXT
Japanese Governmental office
Nippon Medical School Hospital Institutional Review Board
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
+81-3-3822-2131
clinicaltrial@nms.ac.jp
NO
2018 | Year | 01 | Month | 01 | Day |
Unpublished
0
Terminated
2017 | Year | 12 | Month | 17 | Day |
2017 | Year | 10 | Month | 06 | Day |
2018 | Year | 01 | Month | 15 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 09 | Month | 30 | Day |
2022 | Year | 03 | Month | 31 | Day |
2017 | Year | 12 | Month | 17 | Day |
2019 | Year | 12 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034643
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