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NCT05350514 Clinical Trial

Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05350514
Other study ID # 22-0608
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 19, 2022
Est. completion date May 31, 2023

Study information
Verified date November 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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) - Stroke - If female, breastfeeding, plan to become pregnant or are pregnant

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PI-2620 tracer
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.

Locations
Country Name City State
United States Lifecourse Epidemiology of Adiposity and Diabetes Center Aurora Colorado

Sponsors (2)
Lead Sponsor Collaborator
University of Colorado, Denver American College of Radiology

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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