Tau PET Imaging for Cognitive Impairment

Enrolling by invitation at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a special brain imaging test, called a Tau PET scan, for individuals of different racial backgrounds with normal cognitive abilities or dementia. The aim is to determine if the scan can enhance understanding and potentially aid in diagnosing cognitive issues. African American men and women aged 30 or older, who are either cognitively normal or experiencing mild cognitive problems or dementia, are eligible to participate. Participants must remain still for 20 minutes during the scan. This trial offers a unique opportunity to contribute to research that could improve future brain health care. As a Phase 2 trial, the research focuses on assessing the imaging test's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Tau PET scan is safe for cognitive impairment studies?

Research has shown that Tau PET scans are generally safe for people. These scans study brain changes in individuals with memory problems or dementia. Tau PET scans allow doctors to see tau proteins in the brain, which are linked to diseases like Alzheimer's.

Studies indicate that Tau PET scans effectively predict cognitive issues. No reports of serious side effects have emerged from these scans. Since this trial is in the middle phase of testing, some evidence suggests that the scans are well-tolerated.

Currently, Tau PET scans are mainly used to gain a clearer understanding of brain activity, aiding doctors in diagnosing cognitive problems more accurately. While studies focus on the effectiveness of the scans, the lack of reported negative effects suggests the procedure is safe.12345

Why are researchers excited about this trial?

Researchers are excited about Tau PET scans for cognitive impairment because these scans offer a unique way to visualize tau protein deposits in the brain, which are closely linked to conditions like Alzheimer's disease. Unlike other diagnostic methods that might rely on cognitive tests or broader imaging techniques, Tau PET scans provide a more precise look at the changes happening in the brain's structure. This can help in earlier and more accurate diagnosis, potentially leading to better-targeted treatments for individuals. By understanding where and how much tau is accumulating, doctors can gain insights that current methods might miss, paving the way for more personalized intervention strategies.

What evidence suggests that the Tau PET scan is effective for cognitive impairment?

Research has shown that tau PET scans are a promising tool for understanding memory and thinking problems, as well as dementia. In this trial, participants will undergo tau PET scans to assess their cognitive status. Previous studies found these scans best predicted which individuals with mild cognitive impairment (MCI) might develop dementia. They strongly correlate with thinking skills, symptoms, and changes in the brain over time. Tau PET scans can diagnose and track memory and thinking decline accurately, often outperforming other methods. They excel at detecting late-stage brain changes linked to serious memory and thinking issues. Overall, tau PET scans are valuable for identifying and managing cognitive problems.46789

Who Is on the Research Team?

NR

Neill R Graff-Radford, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for African American adults aged 30 or older who have either normal cognitive function or dementia. They must be able to lie still for 20 minutes and not have conditions like a prolonged QT interval on an ECG, metal implants, pacemakers, or severe claustrophobia that would prevent MRI scans.

Inclusion Criteria

Subjects who have completed or are scheduled to undergo the neurological evaluation procedures described below.
I am an African American aged 30 or older.

Exclusion Criteria

I do not have any metal implants or a pacemaker that would prevent me from having an MRI.
I can't stay still lying down for 20 minutes.
You have a fear of enclosed spaces and cannot undergo scans.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Tests

Participants undergo neuroimaging tests to gather information on tau positive scans

5 years

Follow-up

Participants are monitored for safety and effectiveness after imaging tests

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tau PET scan
Trial Overview The study is examining the use of Tau PET scans in African Americans to understand more about brain imaging tests across different races in people with normal cognition or dementia.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Normal controlExperimental Treatment1 Intervention
Group II: Mild Cogntive impairmentExperimental Treatment1 Intervention
Group III: DementedExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38857029/
Tau Positron Emission Tomography for Predicting Dementia in ...In this study, tau-PET showed the best performance as a stand-alone marker to predict progression to dementia among individuals with MCI.
The impact of tau-PET in a selected memory clinic cohortExtensive literature provides evidence that tau-PET is strongly associated with cognition, clinical symptoms and neurodegeneration [32–37]. A ...
Plasma p-tau217 and tau-PET predict future cognitive ...Tau-PET has shown excellent diagnostic accuracy and strong associations with both concurrent and longitudinal cognitive decline, outperforming ...
Updated Appropriate Use Criteria for Amyloid and Tau PETThe PET scans should be performed when there is significant uncertainty regarding the etiology of cognitive impairment after a comprehensive ...
The Role of Tau PET Scans in Alzheimer's Research and CareMore reliably, the PET scans are detecting Braak stages five to six, which are very strongly associated with clinically meaningful cognitive ...
Tau PET positivity predicts clinically relevant cognitive ...Our findings suggest that high tau PET uptake is coupled with both Aβ pathology and accelerated cognitive decline.
Tau Positron Emission Tomography for Predicting ...These findings suggest that quantitative tau PET and tau PET visual reads show the greatest promise as a stand-alone prognostic marker for clinical progression ...
Tau PET positivity in individuals with and without cognitive ...The present study aimed to estimate the prevalence of tau proteinopathy as measured by PET in CU participants and in individuals with mild ...
New Guidance for Alzheimer's Imaging Tests | alz.org“Amyloid and tau PET can support and enable earlier and more accurate diagnosis, which is essential to high quality care and treatment for ...
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