MedPath

Neuroimaging Study

Phase 2
Conditions
Cognitive Impairment
Interventions
Combination Product: Tau PET scan
Registration Number
NCT03618186
Lead Sponsor
Mayo Clinic
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
240
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
DementedTau PET scanPatient's that meet dementia criteria
Normal controlTau PET scanCognitively normal volunteers
Mild Cogntive impairmentTau PET scanPerson with cognitive impairment that meet Peterson Criteria
Primary Outcome Measures
NameTimeMethod
Tau positive scans5 years

Percentage of each of the three groups with tau positive scans

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Mayo Clinic Minnesota

🇺🇸

Rochester, Minnesota, United States

Mayo Clinic in Florida

🇺🇸

Jacksonville, Florida, United States

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