Health and Aging Brain Study: Health Disparities Tau Positron Emission Tomography (PET) Scan Study

• Conditions: Alzheimer Disease
• Interventions: Diagnostic Test: PI-2620 tracer for Tau PET scan

• Registration Number: NCT05076331
• Lead Sponsor: University of North Texas Health Science Center

Brief Summary

The purpose of this project is to study the aging brain among participants enrolled in the Health and Aging Brain Study: Health Disparities project . There are a number of things that can influence how people think as they age, including diabetes, depression, as well as our biology. In this study, the investigators seek to study the aging brain by using brain PET scans that create detailed pictures of the brain.

Detailed Description

There are a number of things that can influence how we think as people age, including diabetes, depression, as well as our biology. In this study, the investigators are using PET scans with a tracer to create detailed pictures of the brain. This information will be used to help the investigators understand how the brain ages and in the future could be used to develop better diagnostics and treatments for Alzheimer's disease and memory loss in Mexican Americans, African Americans, and non-Hispanic whites. The goal of this study is to address this disparity by enrolling ethnically diverse participants in this study.

Study Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2021-09-28
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-12
• Last Update Submitted: 2021-10-12
• Study First Posted: 2021-10-13
• Last Update Posted: 2021-10-13
• Primary Completion: 2023-08-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Enrolled in the Health and Aging Brain Study HD: Health Disparities project
2. Provided consent to re-contact
3. Willing and capable of undergoing PET scan of the head

Exclusion Criteria

1. Inability to provide informed consent by self or by proxy.
2. Pregnant or breast feeding women*
3. History of alcoholism or drug dependency/abuse within the last 2 years before screening
4. Hypersensitivity to the active substance or to any of the following excipients is contraindicated: sodium dihydrogen phosphate, phosphoric acid, sodium ascorbate, ethanol (anhydrous), water for injection
5. Participants may not be in this study if they do not meet the safety criteria to undergo imaging procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health and Aging Brain Study Cohort	PI-2620 tracer for Tau PET scan	Health and Aging Brain Study participants age 50 and older.

Primary Outcome Measures

Name	Time	Method
Health Disparities in Aging	Through study completion in 2 years	Examine the prevalence of Tau burden among a multi ethnic cohort

Trial Locations

Locations (1)

University of North Texas Health Science Center; 🇺🇸 Fort Worth, Texas, United States