None listed
Conditions
Interventions
Drug : Subject will receive a single IV injection of SMBT-1.
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for All Participants 1. Participants must be aged 19 years or older and under 80 years. 2. Participants must have completed at least 6 years of formal education. 3. Participants must have a general health status that is consistent with all clinical trial processes, confirmed by laboratory evaluations, physical examinations, and medical history reviews conducted prior to the administration of [18F]SMBT-1. 4. Female participants must either have undergone sterilization surgery (such as oophorectomy or hysterectomy) or be postmenopausal (more than 2 years since menopause). If neither applies, a negative urine pregnancy test must be confirmed, and they must agree to use contraception during the study period. 5. Participants or their legal representatives must sign and date the informed consent form in accordance with applicable regulations. Inclusion Criteria for Cognitively Normal Participants 1. Participants must have no history of cognitive impairment. 2. Participants must score above -1.5 standard deviations of the mean on the Mini Mental State Exam (MMSE), adjusted for education and age. 3. Participants must score above -1 standard deviation of the mean on the delayed recall subtests of the Seoul Neuropsychological Screening Battery (SNSB)-II, specifically the Seoul Verbal Learning Test (SVLT) and the Rey Copy Figure Test (RCFT), adjusted for education and age. 4. Participants must have a Clinical Dementia Rating (CDR) of 0. 5. Participants must have MRI scans that are consistent with normal brain function, obtained during the screening visit, with sufficient diagnostic quality for volume of interest (VOI) and partial volume effect correction. Inclusion Criteria for Degenerative Brain Disease Participants 1. "Degenerative brain diseases," as described in the study protocol and consent form, refer to mild cognitive impairment, Alzheimer’s disease, and non-Alzheimer’s tauopathies, with diagnostic and selection criteria following the definitions in Appendix 3. 2. Participants must complete the MMSE and CDR assessments. 3. Participants must score 4 or below on the Modified Hachinski Ischemic Scale. 4. Participants must have MRI scans that meet the diagnostic criteria for degenerative brain diseases, obtained during the screening visit, with sufficient diagnostic quality for VOI and partial volume effect correction. Inclusion Criteria for Inflammatory Brain Disease Participants 1. "Inflammatory brain diseases," as described in the study protocol and consent form, refer to autoimmune encephalitis, demyelinating diseases, etc., with diagnostic and selection criteria following the definitions in Appendix 3. 2. Participants must be diagnosed with inflammatory brain diseases based on MRI scans, increased white blood cells in cerebrospinal fluid, positive autoantibodies, neurological symptoms, and clinical judgment by a neurologist. 3. Participants must score 4 or below on the Modified Hachinski Ischemic Scale.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for All Participants 1. Participants deemed by the investigator to be unable to complete the trial. 2. Participants with clinically significant abnormalities found during physical examinations or laboratory tests performed during screening that could affect the results of the clinical trial. 3. Participants with known or suspected hypersensitivity/allergy to [18F]SMBT-1 or its excipients. 4. Pregnant or breastfeeding women. 5. Participants with a history of alcohol and/or drug abuse within the past 2 years. 6. Participants with contraindications for MRI or PET (including but not limited to: claustrophobia, presence of a pacemaker, metallic fragments near the eye or spinal cord, or history of cochlear implantation). 7. Participants who have participated in another clinical trial using an investigational medicinal product (IMP) within 30 days prior to this study. Exclusion Criteria for Cognitively Normal Participants 1. Participants with clinically significant medical or neurological conditions (such as stroke, brain tumor, cerebrovascular disease, traumatic brain injury) or other clinically significant abnormalities found in physical, neurological, or laboratory assessments. 2. Participants with a family history of Alzheimer’s disease in two or more direct relatives. Exclusion Criteria for Participants with Degenerative Brain Diseases 1. Participants with neurological disorders (such as traumatic brain injury or brain tumors) or mental disorders (such as schizophrenia or mania) that may affect cognitive abilities, in addition to degenerative brain diseases. 2. Participants with a history of clinically significant severe stroke or cerebrovascular disease shown on brain imaging. 3. Participants who have received anti-inflammatory treatments prior to undergoing [18F]SMBT-1 PET scans. Exclusion Criteria for Participants with Inflammatory Brain Diseases 1. Participants with neurological disorders (such as traumatic brain injury or brain tumors) or mental disorders (such as schizophrenia or mania) that may affect cognitive abilities, in addition to inflammatory brain diseases. 2. Participants with a history of clinically significant severe stroke or cerebrovascular disease shown on brain imaging. 3. Participants who have received anti-inflammatory treatments prior to undergoing [18F]SMBT-1 PET scans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Present the difference in the degree of standardized intake ratio (SUVR) measured using [18F]SMBT-1 PET in volunteers with normal cognitive function and patients with degenerative brain disease and inflammatory brain disease, and present the difference in deposition area between each diagnosis group;Pharmacodynamic properties of [18F]SMBT-1 measured by dynamic PET images (Cmax, Tmax, TAC, SUVR) interest for quantitative [18F]SMBT-1 activation of the brain | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between [18F]SMBT-1 PET and Structural MRI findings;Correlation between [18F]SMBT-1 PET and amyloid PET imaging findings;Intracerebral Standardized Ingestion Coefficient Ratio (SUVR) measured by [18F]SMBT-1 PET images and correlation between age and smoking | — |
Countries
Korea, Republic of
Contacts
Public ContactChang Hwan Sung
Asan Medical Center
Outcome results
None listed