Lifecourse Epidemiology of Adiposity and Diabetes Center
Aurora, Colorado, 80045, United States
NCT Number: NCT05350514
The goal of the study is to characterize preclinical Alzheimer's Disease and related dementias (AD/ADRD) neuropathology in a selected group of young adults with youth-onset diabetes, and an age-similar group of young adults without diabetes.
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Notify Me18 year–40 year
All sexes
Observational
Aurora, Colorado, 80045, United States
The goal of the current proof-of-concept study is to characterize brain structural, functional, and molecular imaging biomarkers of preclinical Alzheimer's Disease and related dementias (AD/ADRD) neuropathology in a selected group of young adults with youth-onset diabetes (Y-DM; type 1 diabetes [T1D], n=5; type 2 diabetes [T2D], n=5) from the SEARCH for Diabetes in Youth study cohort, and an age-similar group of young adults without diabetes (n=5). This study will quantify structural and functional imaging biomarkers of AD/ADRD neuropathology via magnetic resonance imaging by assessing gray matter (GM) volume/cortical thickness, as well as GM and white matter (WM) microstructure, resting state functional network connectivity (rsfMRI), and cerebral blood flow (CBF) and WM hyperintensity volume. This study will additionally quantify brain tau density via positron emission tomography as the gold-standard measure of preclinical AD/ADRD neuropathology.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Following published manufacturer guidelines for Flutemetamol (VizamylTM), Flortaucipir (TauvidTM) and PI-2620 tracer administration162, all participants will be given a 370 MBq (10 mCi) single intravenous bolus (total volume 10mL) of the radiotracer, followed with an intravenous flush of 0.9% sodium chloride injection. Radiotracer administration and participant monitoring will be conducted by trained personnel from the CU-RIC.
Time frame: Baseline
Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR
Time frame: Baseline
Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR
Time frame: Baseline
Structural cerebrovascular disease via Sagittal 3D FLAIR
Time frame: Baseline
Resting-state functional connectivity via Axial T2* EPI fcMRI
Time frame: Baseline
Cerebral blood flow or perfusion via Axial 3D pCASL
Time frame: Baseline
Gray matter and white matter microstructure via Diffusion Kurtosis Imaging
Time frame: Baseline
Tau accumulation via positron emission tomography with PI-2620 radiotracer
Time frame: Baseline
Tau accumulation via positron emission tomography with PI-2620 radiotracer
Time frame: Baseline
Tau accumulation via positron emission tomography with PI-2620 radiotracer
Time frame: Baseline
Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR
Time frame: Baseline
Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR
Time frame: Baseline
Structural cerebrovascular disease via Sagittal 3D FLAIR
Time frame: Baseline
Cerebral blood flow via Axial 3D pCASL
Time frame: Baseline
Gray matter and white matter microstructure via Diffusion Kurtosis Imaging
University of Colorado, Denver
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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