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

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ClinicalTrials.gov Identifier: NCT02676843
Recruitment Status : Completed
First Posted : February 8, 2016
Results First Posted : December 6, 2019
Last Update Posted : December 6, 2019
Sponsor:
Collaborator:
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. Up to three 18F-AV-1451 scans will be performed (one per year) 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

Detailed Description:
Approximately 40% of cases of Frontotemporal lobar Degeneration (FTLD) are also associated with abnormal deposition of tau protein. The purpose of this study is to image MAPT mutation carriers and their non-carrier relatives in order to study the use of this tracer as a biomarker in Frontotemporal Lobar Degeneration with tau deposition (FTLD-tau).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 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
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 25, 2018
Actual Study Completion Date : November 25, 2018


Arm Intervention/treatment
Experimental: 18F-AV-1451
Subjects who are microtubule associated protein tau (MAPT) family carriers and non-carriers 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.
Other Name: [18F]AV-1451




Primary Outcome Measures :
  1. SUVR of 18F-AV-1451 [ Time Frame: Baseline, 12-month follow up ]
    Regional tau deposition will be measured as standardized uptake value ratio (SUVR) of 18F-AV-1451. SUVR (80-100 min post-injection) for 18F-AV-1451 will be calculated two ways: 1) using cerebellar crus as a reference region, and 2) using the Parametric Estimation of Reference Signal Intensity (PERSI) method to create individual white matter reference regions. Binding in the inferior temporal lobe/cortex was used as the primary outcome.



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

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 ClinicalTrials.gov identifier (NCT number): NCT02676843


Locations
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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
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Principal Investigator: Edward Huey, MD Columbia University
  Study Documents (Full-Text)

Documents provided by Edward D Huey, MD, Columbia University:

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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 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2016    Key Record Dates
Results First Posted: December 6, 2019
Last Update Posted: December 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified clinical characteristics subjects such as age, mutation and rating scale/score of mental state in the manuscript.
Time Frame: Availability of the manuscript through journal editors
Access Criteria: Availability of the manuscript through journal editors

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edward D Huey, MD, Columbia University:
FTLD
FTD
Additional relevant MeSH terms:
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Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Tauopathies
Frontotemporal Lobar Degeneration
Dementia
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