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

Alzheimer Disease Clinical Trial

Official title:

Health and Aging Brain Study: Health Disparities Tau PET Scan Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05076331
• Other study ID #: 2020-125
• Status: Enrolling by invitation
• Start date: April 20, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2021
• Source: University of North Texas Health Science Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3000
• Est. completion date: December 30, 2023
• Est. primary completion date: August 30, 2023
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Diagnostic Test:
• PI-2620 tracer for Tau PET scan
Tau PET scans are obtained using PI-2620 tracer provided by Life Medical Imaging.

Locations

Country	Name	City	State
United States	University of North Texas Health Science Center	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of North Texas Health Science Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Disparities in Aging	Examine the prevalence of Tau burden among a multi ethnic cohort	Through study completion in 2 years