Clinical trial

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

Name

22-0608

Description

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.

Trial arms

Trial start

2022-07-19

Estimated PCD

2023-05-31

Trial end

2023-05-31

Status

Completed

Treatment

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.

Arms:

NDM, T1D, T2D

Size

Primary endpoint

Temporal lobe volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes

Baseline

Temporal lobe cortical thickness in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes

Baseline

Whole brain white matter hyperintensities volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes

Baseline

Regional homogeneity of the default mode network in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes

Baseline

Whole brain cerebral blood flow in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes

Baseline

Whole brain fractional anisotropy in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes

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

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

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

Baseline

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '1 Day', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}

Updated at

2023-11-30

1 organization

1 product

5 indications

Organization

University of Colorado Denver

Product

Indication

Indication

Indication

Indication

Indication