NCT05076331

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

September 28, 2021

Last Update Submit

October 12, 2021

Conditions

Keywords

Alzheimer's DiseaseTau PET ScanHealth DisparitiesBrain Aging

Outcome Measures

Primary Outcomes (1)

  • Health Disparities in Aging

    Examine the prevalence of Tau burden among a multi ethnic cohort

    Through study completion in 2 years

Study Arms (1)

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

Interventions

Tau PET scans are obtained using PI-2620 tracer provided by Life Medical Imaging.

Health and Aging Brain Study Cohort

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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. .

You may qualify if:

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

You may not qualify if:

  • Inability to provide informed consent by self or by proxy.
  • Pregnant or breast feeding women\*
  • History of alcoholism or drug dependency/abuse within the last 2 years before screening
  • 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
  • Participants may not be in this study if they do not meet the safety criteria to undergo imaging procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 13, 2021

Study Start

April 20, 2021

Primary Completion

August 30, 2023

Study Completion

December 30, 2023

Last Updated

October 13, 2021

Record last verified: 2021-10

Locations