Tau PET Imaging in African Americans

June 20, 2023 updated by: Neill R. Graff-Radford, M.D., Mayo Clinic
The researchers are trying to gather information and learn more about imaging tests in racially different people who are cognitively normal or have dementia.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female African Americans 30 years of age or older
  • Subjects who have completed or are scheduled to undergo the neurological evaluation procedures described below.

Exclusion Criteria:

  • Subjects unable to lie down without moving for 20 minutes.
  • Women who are pregnant or cannot stop breast feeding for 24 hours.
  • Claustrophobic patients unable to tolerate the scans.
  • Subjects with a prolonged QT interval (as demonstrated by ECG test) cannot participate in the Tau-PET scans.
  • Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc, since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal control
Cognitively normal volunteers
Combination product: Tau PET scan
Patient will receive a dose of flutaucipir and be scanned appropriately
Experimental: Mild Cogntive impairment
Person with cognitive impairment that meet Peterson Criteria
Combination product: Tau PET scan
Patient will receive a dose of flutaucipir and be scanned appropriately
Experimental: Demented
Patient's that meet dementia criteria
Combination product: Tau PET scan
Patient will receive a dose of flutaucipir and be scanned appropriately

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tau positive scans
Time Frame: 5 years
Percentage of each of the three groups with tau positive scans
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Neill R Graff-Radford, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2018

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-008710
  • 5P50AG016574-20 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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