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Tau PET Imaging in African Americans

Primary Purpose

Cognitive Impairment

Status

Enrolling by invitation

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tau PET scan

About this trial

This is an interventional diagnostic trial for Cognitive Impairment focused on measuring African Americans, neurological exam, Dementia, Alzheimer's Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mayo Clinic in Florida
Mayo Clinic Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Normal control

Mild Cogntive impairment

Demented

Arm Description

Cognitively normal volunteers

Person with cognitive impairment that meet Peterson Criteria

Patient's that meet dementia criteria

Outcomes

Primary Outcome Measures

Tau positive scans

Percentage of each of the three groups with tau positive scans

Secondary Outcome Measures

Full Information

NCT ID

NCT03618186

First Posted

August 2, 2018

Last Updated

June 20, 2023

Sponsor

Mayo Clinic

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT03618186

Brief Title

Tau PET Imaging in African Americans

Official Title

Tau PET Imaging in African Americans

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

November 26, 2018 (Actual)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Impairment

Keywords

African Americans, neurological exam, Dementia, Alzheimer's Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Normal control

Arm Type

Experimental

Arm Description

Cognitively normal volunteers

Arm Title

Mild Cogntive impairment

Arm Type

Experimental

Arm Description

Person with cognitive impairment that meet Peterson Criteria

Arm Title

Demented

Arm Type

Experimental

Arm Description

Patient's that meet dementia criteria

Intervention Type

Combination Product

Intervention Name(s)

Tau PET scan

Intervention Description

Patient will receive a dose of flutaucipir and be scanned appropriately

Primary Outcome Measure Information:

Title

Tau positive scans

Description

Percentage of each of the three groups with tau positive scans

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neill R Graff-Radford, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Mayo Clinic Minnesota

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Tau PET Imaging in African Americans

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