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Tau PET Imaging in African Americans

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03618186
Collaborator
National Institute on Aging (NIA) (NIH)
90
Enrollment
1
Location
3
Arms
65.1
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Tau PET scan
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Tau PET Imaging in African Americans
Actual Study Start Date :
Nov 26, 2018
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Normal control

Cognitively normal volunteers

Combination Product: Tau PET scan
Patient will receive a dose of flutaucipir and be scanned appropriately
Experimental: Mild Cogntive impairment

Person with cognitive impairment that meet Peterson Criteria

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

Patient's that meet dementia criteria

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

Outcome Measures

Primary Outcome Measures

  1. Tau positive scans [5 years]

    Percentage of each of the three groups with tau positive scans

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Florida Jacksonville Florida United States 32224

Sponsors and Collaborators

  • Mayo Clinic
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Neill R Graff-Radford, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Neill R. Graff-Radford, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03618186
Other Study ID Numbers:
  • 17-008710
  • 5P50AG016574-20
First Posted:
Aug 7, 2018
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Neill R. Graff-Radford, M.D., Principal Investigator, Mayo Clinic
African Americans
neurological exam
Dementia
Alzheimer's Disease
Additional relevant MeSH terms:
Cognitive Dysfunction

Study Results

No Results Posted as of Feb 1, 2022