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

Sponsor
University of North Texas Health Science Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05076331
Collaborator
(none)
3,000
Enrollment
1
Location
32.3
Anticipated Duration (Months)
92.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: PI-2620 tracer for Tau PET scan

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 Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Health and Aging Brain Study: Health Disparities Tau PET Scan Study
Actual Study Start Date :
Apr 20, 2021
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Health Disparities in Aging [Through study completion in 2 years]

    Examine the prevalence of Tau burden among a multi ethnic cohort

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of North Texas Health Science CenterFort WorthTexasUnited States76107

Sponsors and Collaborators

  • University of North Texas Health Science Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Texas Health Science Center
ClinicalTrials.gov Identifier:
NCT05076331
Other Study ID Numbers:
  • 2020-125
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of North Texas Health Science Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021