---
title: "Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study"
nct_id: NCT05350514
overall_status: COMPLETED
sponsor: University of Colorado, Denver
study_type: OBSERVATIONAL
primary_condition: Diabetes Mellitus, Type 1
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05350514.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05350514"
ct_last_update_post_date: 2023-11-30
last_seen_at: "2026-05-12T07:27:13.513Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study

**NCT ID:** [NCT05350514](https://clinicaltrials.gov/study/NCT05350514)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 14
- **Lead Sponsor:** University of Colorado, Denver
- **Collaborators:** American College of Radiology
- **Conditions:** Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes, Youth Onset
- **Start Date:** 2022-07-19
- **Completion Date:** 2023-05-31
- **CT.gov Last Update:** 2023-11-30

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 40 Years
- **Sex:** ALL
- **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)
* Stroke
* If female, breastfeeding, plan to become pregnant or are pregnant
```

## Arms

- **T1D** — Young adults with youth-onset type 1 diabetes (n=5) from the SEARCH for Diabetes in Youth study cohort
- **T2D** — Young adults with youth-onset type 2 diabetes (n=5) from the SEARCH for Diabetes in Youth study cohort
- **NDM** — Age-similar group of young adults without diabetes (n=5)

## Interventions

- **PI-2620 tracer** (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.

## Primary Outcomes

- **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 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
- **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
- **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
- **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 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
- **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
- **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

## Secondary Outcomes

- **Whole brain gray matter volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes** _(time frame: Baseline)_
- **Whole brain white matter volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes** _(time frame: Baseline)_
- **Perivascular space in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes** _(time frame: Baseline)_
- **Atlas based region of interest cerebral blood flow in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes** _(time frame: Baseline)_
- **Atlas based region of interest fractional anisotropy in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes** _(time frame: Baseline)_

## Locations (1)

- Lifecourse Epidemiology of Adiposity and Diabetes Center, Aurora, Colorado, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.lifecourse epidemiology of adiposity and diabetes center|aurora|colorado|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05350514.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05350514*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*