Brain Aging in Mexican AmericansNCT04324541
Health & Aging Brain Study: Health Disparities TAU Project
An observational study of Brain Aging in Mexican Americans, run by Sid E. O'Bryant at 1 site in United States.
Trial summary
By doing this study we are trying to learn more about brain aging in Mexican Americans. Participants will be asked to complete a screening visit to determine if it is safe to undergo a PET scan. If eligible, participants will undergo a medical procedure that takes a picture of their brain. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Brain Aging in Mexican Americans
- What is being tested?
- PET scan of the brain with Flortaucipir
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 20 Apr 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mexican Americans that participated in the Health \& Aging Brain Study Amyloid Project
Who may be able to join
- Participation in the Health \& Aging Brain Study: Health Disparities Amyloid Project
Who cannot join
- Not a participant in the Health \& Aging Brain Study: Health Disparites Amyloid Project
- Medical condition that precludes safe use of PET tracer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Texas Health Science Center Institute for Translational Research
Fort Worth, Texas, 76107
About this study
By doing this study we are trying to learn more about brain aging in Mexican Americans.
Participants will be asked to complete a screening visit to determine if it is safe to undergo a PET scan.
If eligible, participants will undergo a medical procedure that takes a picture of their brain. This procedure is called a PET scan of the brain.
- Conditions
- Brain Aging in Mexican Americans
- Being tested
- PET scan of the brain with Flortaucipir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scan of the brain with FlortaucipirDiagnostic test
PET scan of the brain with non FDA approved Radio tracer.
| Study group | Role | What they receive |
|---|---|---|
| Mexican American Adults | No intervention Receives: Diagnostic Test: PET scan of the brain with Flortaucipir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tau Accumulation Measured by PET Imaging
Tau PET scan completed and radiologist reviewed imaging and provided a report on whether or not Tau protein was present in the brain.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start23 Sep 2019
- Primary completion17 Oct 2019
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain Aging in Mexican AmericansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sid E. O'Bryant
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sid E. O'Bryant, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324541
- Sponsor's protocol ID
- 2019-192
- Status last verified
- May 2024
- First submitted
- 24 Mar 2020
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health & Aging Brain Study: Health Disparities TAU Project
- ClinicalTrials.gov ID
- NCT04324541
- Acronym / sponsor ID
- 2019-192
- Conditions
- Brain Aging in Mexican Americans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sid E. O'BryantUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Posted 17 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By doing this study we are trying to learn more about brain aging in Mexican Americans.
Participants will be asked to complete a screening visit to determine if it is safe to undergo a PET scan.
If eligible, participants will undergo a medical procedure that takes a picture of their brain. This procedure is called a PET scan of the brain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mexican American Adults | – | Diagnostic Test: PET scan of the brain with FlortaucipirNo intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mexican Americans that participated in the Health \& Aging Brain Study Amyloid Project
Key inclusion criteria (1 listed)
- Participation in the Health \& Aging Brain Study: Health Disparities Amyloid Project
Key exclusion criteria (2 listed)
- Not a participant in the Health \& Aging Brain Study: Health Disparites Amyloid Project
- Medical condition that precludes safe use of PET tracer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scan of the brain with FlortaucipirPET scan of the brain with non FDA approved Radio tracer. | Diagnostic test | Mexican American Adults |
Primary outcome
Tau Accumulation Measured by PET Imaging
Time frame: 4 weeks
Tau PET scan completed and radiologist reviewed imaging and provided a report on whether or not Tau protein was present in the brain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Aging in Mexican Americans, run by Sid E. O'Bryant at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tau Accumulation Measured by PET Imaging (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.