Diabetes Mellitus, traumatic brain injury, depression, mild cognitive impairment
Conditions
Interventions
Initial evaluation: [18F]flrobetapir PET (370MBq), MRI, Neuropsychological examination, blood test, urine test 1st year evaluation: Neuropsychological examination, blood test, urine test 2nd year
Sponsors
Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| examination at the initial evaluation: signal of [18F]flrobetapir | — |
Secondary
| Measure | Time frame |
|---|---|
| examination at the initial evaluation, 1 year evaluation, 2 year evaluation: cognitive function blood test urine test clinical symptoms diagnosis | — |
Countries
Japan
Contacts
Public ContactAmane Tateno
Nippon Medical School Department of Neuropsychiatry
Outcome results
None listed