Trial record 2 of 5 for:    MAPT

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02676843
Recruitment Status : Enrolling by invitation
First Posted : February 8, 2016
Last Update Posted : October 27, 2016
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Edward D Huey, MD, Columbia University

Brief Summary:
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 or disease Intervention/treatment Phase
Frontotemporal Lobar Degeneration FTLD Frontotemporal Dementia FTD Tauopathies Drug: 18F-AV-1451 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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