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Tau PET Imaging in African Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03618186
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2018
Last Update Posted : February 8, 2023
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Neill R. Graff-Radford, M.D., Mayo Clinic

Study Description
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Brief Summary:
The researchers are trying to gather information and learn more about imaging tests in racially different people who are cognitively normal or have dementia.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Combination Product: Tau PET scan Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tau PET Imaging in African Americans
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Tau positive scans [ Time Frame: 5 years ]
    Percentage of each of the three groups with tau positive scans


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618186


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Neill R Graff-Radford, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Neill R. Graff-Radford, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03618186    
Other Study ID Numbers: 17-008710
5P50AG016574-20 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neill R. Graff-Radford, M.D., Mayo Clinic:
African Americans
neurological exam
Dementia
Alzheimer's Disease
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders