Tau PET Imaging in African Americans

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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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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