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Clinical Trial Details

Trial ID: L4838
Source ID: NCT05350514
Associated Drug: Pi-2620 Tracer
Title: Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2|Diabetes, Youth Onset
Interventions: DRUG: PI-2620 tracer
Outcome Measures: Primary: Temporal lobe volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR, Baseline|Temporal lobe cortical thickness in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR, Baseline|Whole brain white matter hyperintensities volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Structural cerebrovascular disease via Sagittal 3D FLAIR, Baseline|Regional homogeneity of the default mode network in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Resting-state functional connectivity via Axial T2\* EPI fcMRI, Baseline|Whole brain cerebral blood flow in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Cerebral blood flow or perfusion via Axial 3D pCASL, Baseline|Whole brain fractional anisotropy in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Gray matter and white matter microstructure via Diffusion Kurtosis Imaging, Baseline|Standardized uptake value ratio for hippocampal to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Tau accumulation via positron emission tomography with PI-2620 radiotracer, Baseline|Standardized uptake value ratio for entorhinal to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Tau accumulation via positron emission tomography with PI-2620 radiotracer, Baseline|Standardized uptake value ratio for cerebral to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Tau accumulation via positron emission tomography with PI-2620 radiotracer, Baseline | Secondary: Whole brain gray matter volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR, Baseline|Whole brain white matter volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR, Baseline|Perivascular space in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Structural cerebrovascular disease via Sagittal 3D FLAIR, Baseline|Atlas based region of interest cerebral blood flow in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Cerebral blood flow via Axial 3D pCASL, Baseline|Atlas based region of interest fractional anisotropy in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes, Gray matter and white matter microstructure via Diffusion Kurtosis Imaging, Baseline
Sponsor/Collaborators: Sponsor: University of Colorado, Denver | Collaborators: American College of Radiology
Gender: ALL
Age: ADULT
Phases:
Enrollment: 14
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-07-19
Completion Date: 2023-05-31
Results First Posted:
Last Update Posted: 2023-11-30
Locations: Lifecourse Epidemiology of Adiposity and Diabetes Center, Aurora, Colorado, 80045, United States
URL: https://clinicaltrials.gov/show/NCT05350514