SNPMiner Trials by Shray Alag


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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

Description: PET/CT imaging will be used to evaluate neuroinflammation in the brain using the investigational radiotracer [11C]PBR28 followed by a second investigational radiotracer [18F]NOS. Each subject will have two positron emission tomography/computed tomography (PET/CT) scan sessions performed on the same day, first with [11C]PBR28 followed by [18F]NOS.
Type: Drug
Group Labels: 2

Healthy volunteer patient with Alzheimer disease


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 years

Secondary 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 years

Purpose: 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.



HPO Nodes


HPO: