healthy male volunteers AMPA receptor, K-2 PET, test-retest, repeatability
Conditions
Interventions
Sponsors
Abe Hiroki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Participants must be healthy volunteers who meet all of the following inclusion criteria. At the Time of Informed Consent Inclusion Criteria Male participants aged 20 years or older and under 40 years at the time of obtaining informed consent. No history of psychiatric or neurological disorders. Individuals who were assessed using the MacArthur Competence Assessment Tool (MacCAT) and judged to have sufficient capacity to provide informed consent, and who provided written informed consent to participate in this study. Note a) To ensure consistency with existing datasets, the lower age limit was set at 20 years, rather than 18 years. At the Time of Provisional Registration Inclusion Criteria Individuals who did not meet the diagnostic criteria for any psychiatric disorder according to the Structured Clinical Interview for DSM-5 (SCID/DSM-5) and the International Classification of Diseases, 10th Revision (ICD-10).
Exclusion criteria
Exclusion criteria: Only healthy volunteers who do not meet any of the following exclusion criteria will be eligible for participation in this study. At the Time of Informed Consent (Only inclusion criteria will be confirmed at this stage.) At the Time of Provisional Registration Exclusion Criteria 1. Current use of psychotropic medications, including antidepressants, hypnotics/sedatives, anxiolytics, or antipsychotic drugs. 2. Hypersensitivity to alcohol. 3. Presence of neurological disorders, including neurodegenerative diseases or a history of cerebral hemorrhage or cerebral infarction. 4. History of suicide attempt or self harm. 5. Presence of psychiatric disorders related to past psychological trauma. 6. History of brain tumor. 7. History of epilepsy. 8. Currently receiving treatment for any other medical condition at a medical institution. 9. Substance related disorder within the past 6 months (excluding nicotine and caffeine). 10. Unsuitability for 3 tesla MRI scanning, including the presence of non MRI compatible implanted metallic devices, tattoos larger than a small single point tattoo (including cosmetic tattoos), severe claustrophobia, body size incompatible with the MRI scanner, or significant structural brain abnormalities (including congenital or traumatic abnormalities). 11. Abnormal vital signs at screening (systolic blood pressure greater than or equal to 140 mmHg, heart rate greater than or equal to 80 beats/min, or body temperature reater than or equal to 37.5), unless the principal investigator or sub-investigator determines that participation in the clinical study is medically acceptable after comprehensive consideration of other relevant findings. 12. Donation of 400 mL of whole blood within 3 months, 200 mL of whole blood within 1 month, or component blood donation (plasma or platelet donation) within 2 weeks prior to the scheduled PET examination. 13. Participation in any investigational or clinical trial involving unapproved nuclear medicine procedures within 6 months prior to provisional registration. 14. Participation in any other investigational or clinical trial involving invasive procedures or interventions within 12 weeks prior to provisional registration. 15. Any other condition for which the principal investigator or sub investigator judges the individual to be unsuitable as a study participant. At the Time of Final Registration Exclusion Criteria 1. Use of prescription medications or over the counter drugs (including herbal and traditional Japanese medicines), other than psychotropic medications, within 1 week prior to the PET examination. 2. Positive result for substances of abuse on urine drug screening. 3. Presence of any of the following abnormal laboratory values at the time of final registration: Serum creatinine greater than or equal to 1.5 mg/dL Aspartate aminotransferase (AST) greater than or equal to 150 IU/L Alanine aminotransferase (ALT) greater than or equal to 150 IU/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The repeatability of [11C]K-2 standardized uptake value ratios (SUVRs) between PET1 and PET2 will be evaluated using the coefficient of variation (CV) for each brain volume of interest (VOI) based on the Hammers Atlas. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Agreement between the two measurements (test and retest) will be assessed using Bland Altman analysis. Specifically, the following parameters will be calculated: Limits of Agreement (LoA): the range within which the differences between the two measurements fall. Bias: the systematic difference (mean difference) between the two measurements. 2. Inter-subject agreement of SUVRs will be evaluated using the intraclass correlation coefficient (ICC). | — |
Contacts
Public ContactToshihito Sahara
Yokohama City University Hospital
Outcome results
None listed