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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes, Youth Onset; Diabetes Mellitus, Type 2

Treatments: Drug: PI-2620 tracer

Study type: Observational

Funder types: Other

Identifiers

NCT05350514

22-0608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

14 participants in 3 patient groups

T1D

Description:

Young adults with youth-onset type 1 diabetes (n=5) from the SEARCH for Diabetes in Youth study cohort

Treatment:

Drug: PI-2620 tracer

T2D

Description:

Young adults with youth-onset type 2 diabetes (n=5) from the SEARCH for Diabetes in Youth study cohort

Treatment:

Drug: PI-2620 tracer

NDM

Description:

Age-similar group of young adults without diabetes (n=5)

Treatment:

Drug: PI-2620 tracer