Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Whole brain white matter hyperintensities volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Part of the SEARCH for Diabetes in Youth study cohort or
- •Age 18-40
- •Without diabetes
Exclusion Criteria
- •Head trauma with loss of consciousness >30 minutes
- •Claustrophobia
- •Metal in the body
- •Major psychiatric disorder (eg. schizophrenia, bipolar, and major depression)
- •Neurological conditions affecting cognition (eg. epilepsy)
- •If female, breastfeeding, plan to become pregnant or are pregnant
Arms & Interventions
NDM
Age-similar group of young adults without diabetes (n=5)
Intervention: PI-2620 tracer (Drug)
T1D
Young adults with youth-onset type 1 diabetes (n=5) from the SEARCH for Diabetes in Youth study cohort
Intervention: PI-2620 tracer (Drug)
T2D
Young adults with youth-onset type 2 diabetes (n=5) from the SEARCH for Diabetes in Youth study cohort
Intervention: PI-2620 tracer (Drug)
Outcomes
Primary Outcomes
Whole brain white matter hyperintensities volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
Time Frame: Baseline
Structural cerebrovascular disease via Sagittal 3D FLAIR
Whole brain cerebral blood flow in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
Time Frame: Baseline
Cerebral blood flow or perfusion via Axial 3D pCASL
Standardized uptake value ratio for entorhinal to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
Time Frame: Baseline
Tau accumulation via positron emission tomography with PI-2620 radiotracer
Temporal lobe volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
Time Frame: Baseline
Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR
Temporal lobe cortical thickness in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
Time Frame: Baseline
Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR
Whole brain fractional anisotropy in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
Time Frame: Baseline
Gray matter and white matter microstructure via Diffusion Kurtosis Imaging
Standardized uptake value ratio for cerebral to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
Time Frame: Baseline
Tau accumulation via positron emission tomography with PI-2620 radiotracer
Regional homogeneity of the default mode network in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
Time Frame: Baseline
Resting-state functional connectivity via Axial T2\* EPI fcMRI
Standardized uptake value ratio for hippocampal to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
Time Frame: Baseline
Tau accumulation via positron emission tomography with PI-2620 radiotracer
Secondary Outcomes
- Whole brain gray matter volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes(Baseline)
- Atlas based region of interest fractional anisotropy in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes(Baseline)
- Perivascular space in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes(Baseline)
- Atlas based region of interest cerebral blood flow in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes(Baseline)
- Whole brain white matter volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes(Baseline)