Alzheimer DiseaseNCT05076331
Health and Aging Brain Study: Health Disparities Tau Positron Emission Tomography (PET) Scan Study
An observational study of Alzheimer Disease, run by University of North Texas Health Science Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- PI-2620 tracer for Tau PET scan
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
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. .
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Texas Health Science Center
Fort Worth, Texas, 76107
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- PI-2620 tracer for Tau PET scan
- Keywords
- Alzheimer's Disease, Tau PET Scan, Health Disparities, Brain Aging
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PI-2620 tracer for Tau PET scanDiagnostic test
Tau PET scans are obtained using PI-2620 tracer provided by Life Medical Imaging.
| Study group | Role | What they receive |
|---|---|---|
| Health and Aging Brain Study Cohort | Health and Aging Brain Study participants age 50 and older. Receives: Diagnostic Test: PI-2620 tracer for Tau PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Disparities in Aging
Examine the prevalence of Tau burden among a multi ethnic cohort
Measured: Through study completion in 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start20 Apr 2021
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076331
- Sponsor's protocol ID
- 2020-125
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Aging Brain Study: Health Disparities Tau PET Scan Study
- ClinicalTrials.gov ID
- NCT05076331
- Acronym / sponsor ID
- 2020-125
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Tau PET Scan, Health Disparities, Brain Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health and Aging Brain Study Cohort | – | Diagnostic Test: PI-2620 tracer for Tau PET scanHealth and Aging Brain Study participants age 50 and older. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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. .
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| PI-2620 tracer for Tau PET scanTau PET scans are obtained using PI-2620 tracer provided by Life Medical Imaging. | Diagnostic test | Health and Aging Brain Study Cohort |
Primary outcome
Health Disparities in Aging
Time frame: Through study completion in 2 years
Examine the prevalence of Tau burden among a multi ethnic cohort
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
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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 Alzheimer Disease, run by University of North Texas Health Science Center 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. 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?
Results are not available in the source record.
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?
Health Disparities in Aging (time frame: Through study completion in 2 years). 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 13 Oct 2021.