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NCT03618186 Clinical Trial

Tau PET Imaging in African Americans

Cognitive Impairment Clinical Trial

Official title:
Tau PET Imaging in African Americans

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03618186
Other study ID # 17-008710
Secondary ID 5P50AG016574-20
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date November 26, 2018
Est. completion date May 2025

Study information
Verified date June 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 240
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Tau PET scan
Patient will receive a dose of flutaucipir and be scanned appropriately

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tau positive scans Percentage of each of the three groups with tau positive scans 5 years
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