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Trial record 2 of 5 for:    MAPT

Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations

This study is enrolling participants by invitation only.
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Edward D Huey, MD, Columbia University Identifier:
First received: January 15, 2016
Last updated: February 4, 2016
Last verified: February 2016
The study will investigate the ability of a new PET tracer, 18F-AV-1451, to detect depositions of a protein, called tau, in the brains of people with a mutation in the tau gene that causes deposition of the protein, and in people without the mutation. A single 18F-AV-1451 scan will be performed on control subjects without MAPT mutations, presymptomatic mutation carriers, and symptomatic mutation carriers.

Condition Intervention Phase
Frontotemporal Lobar Degeneration
Frontotemporal Dementia
Drug: 18F-AV-1451
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations

Resource links provided by NLM:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Evidence of Tau deposition on PET scan [ Time Frame: Through completion of PET scan, approximately 30 minutes ] [ Designated as safety issue: Yes ]
    Each subject's PET scan will be qualitatively examined for tau positivity.

Estimated Enrollment: 16
Study Start Date: December 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 18F-AV-1451
Subjects will receive 18F-AV-1451 by injection, and undergo a Positron Emission Tomography (PET) scan, which will then be qualitatively analyzed to examine tau deposition in the brain.
Drug: 18F-AV-1451
A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Members of families with established MAPT mutations, who either have the capacity to consent to participate in the protocol, or else have designated a surrogate/proxy to consent to participate in this study

Exclusion Criteria:

  • Unwillingness to participate
  • Usage of medication which significantly prolongs QT interval
  • Pregnancy or plans for pregnancy within 90 days after participating in study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02676843

United States, New York
Morton A. Kreitchman PET Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Edward Huey, MD Columbia University
Principal Investigator: William C Kreisl, MD Columbia University
  More Information

Responsible Party: Edward D Huey, MD, Assistant Professor of Psychiatry and Neurology, Columbia University Identifier: NCT02676843     History of Changes
Other Study ID Numbers: AAAP4551  R01NS076837 
Study First Received: January 15, 2016
Last Updated: February 4, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Lobar Degeneration
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms processed this record on September 28, 2016