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Report for Clinical Trial NCT04274998
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Evaluation of in Vivo Neuroinflammation in Alzheimer's Disease Using Novel Positron Emission Tomography (PET/CT) Imaging
This research study is being done to learn more about inflammation in the brain using Positron Emission Tomography/Computed Tomography (PET/CT) imaging in people with Alzheimer's Disease/Mild Cognitive Impairment or healthy controls. If the subject agrees to be in this study, she/ he will have two types of PET/CT scans on the same day. The subject may have a screening visit before the PET/CT scan visit if the investigator needs to confirm the subject is able to be in the study. A blood sample will be taken before the scans. Additional blood samples will be taken during the PET scans. Subjects must also agree to have an MRI scan for this research study if she/he has not had a recent scan that the study doctor decides can be used for this study.
NCT04274998 Alzheimer Disease Healthy Volunteer MeSH:Alzheimer Disease
HPO:Alzheimer disease
1 Interventions
Name: [11C]PBR28 and[18F]NOS
Primary Outcomes
Description: The primary outcome measure will be comparison of whole brain GM binding between controls and the MCI/AD group. the investigator will compare groups with a t-test. the investigator will evaluate the correlation of whole brain GM binding of 11C-PBR28 and 18F-NOS.
Measure: understanding the uptake of [18F]NOS in the human brain in AD/MCI and Healthy Controls and compare to same-day [11C]PBR28 uptake using PET/CT scan Time: 3 yearsSecondary Outcomes
Description: Secondary outcome measures for will include regional and voxel-wise comparisons between binding of the tracers. Correlation between regional 11C-PBR28 or 18F-NOS binding and either amyloid PET SUVR (calculated with cerebellar gray matter reference) or GM volumetric measurements will be evaluated using Pearson's r and rank sum correlation initially using false discovery rate (FDR)-corrected<0.05 statistical thresholds.
Measure: Comparing the patterns of [18F]NOS and [11C]PBR28 brain uptake with patterns of cerebral amyloidosis and neurodegeneration using PET/CT Time: 3 yearsPurpose: Other
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs6971
3. A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be negative by the study PI. 4. High affinity carrier of the rs6971 TSPO polymorphism (whole genome sequencing is available from the UPenn ADC research cohort and will be interrogated for this polymorphism) 5. Mini-mental status exam (MMSE) score of 28 or higher per ADC database.
3. A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be positive by the study PI. 4. High affinity carrier of the rs6971 TSPO polymorphism (whole genome sequencing is available from the UPenn ADC research cohort and will be interrogated for this polymorphism) 5. Mini-mental status exam (MMSE) score of 14-27 per ADC database.