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

October 12, 2021 updated by: University of North Texas Health Science Center

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76107
        • University of North Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants of the multi ethnic "Health and Aging Brain Study Health Disparities" .Men and women age 50 and above that may or may not have cognitive impairment. .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Health and Aging Brain Study Cohort
Health and Aging Brain Study participants age 50 and older.
Diagnostic test: PI-2620 tracer for Tau PET scan
Tau PET scans are obtained using PI-2620 tracer provided by Life Medical Imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Disparities in Aging
Time Frame: Through study completion in 2 years
Examine the prevalence of Tau burden among a multi ethnic cohort
Through study completion in 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Texas Health Science Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-125

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on PI-2620 tracer for Tau PET scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe