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

NCT ID: NCT05350514

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-19

Study Completion Date

2023-05-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes, Youth Onset

Keywords

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Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes, Youth Onset Magnetic Resonance Imaging Positron Emission Tomography Imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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T1D

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

PI-2620 tracer

Intervention Type DRUG

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.

T2D

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

PI-2620 tracer

Intervention Type DRUG

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.

NDM

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

PI-2620 tracer

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American College of Radiology

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allison Shapiro, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Christopher T Whitlow, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Lifecourse Epidemiology of Adiposity and Diabetes Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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22-0608

Identifier Type: -

Identifier Source: org_study_id