Tau PET Imaging in African Americans

Mayo Clinic

Status and phase: Invitation-only; Phase 2

Conditions: Cognitive Impairment

Treatments: Combination Product: Tau PET scan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03618186

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

17-008710

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Normal control

Experimental group

Description:

Cognitively normal volunteers

Treatment:

Combination Product: Tau PET scan

Mild Cogntive impairment

Experimental group

Description:

Person with cognitive impairment that meet Peterson Criteria

Treatment:

Combination Product: Tau PET scan

Demented

Experimental group

Description:

Patient's that meet dementia criteria

Treatment:

Combination Product: Tau PET scan