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.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Edward D Huey, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT02676843
First received: January 15, 2016
Last updated: February 4, 2016
Last verified: February 2016
  Purpose
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
FTLD
Frontotemporal Dementia
FTD
Tauopathies
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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT02676843

Locations
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)
Investigators
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
ClinicalTrials.gov 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:
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Lobar Degeneration
Tauopathies
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 21, 2016