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

NCT ID: NCT02676843

Last Updated: 2019-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-11-25

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Frontotemporal Lobar Degeneration (FTLD) Frontotemporal Dementia (FTD) Tauopathies

Keywords

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FTLD FTD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

18F-AV-1451

Intervention Type DRUG

A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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[18F]AV-1451

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Edward D Huey, MD

Assistant Professor of Psychiatry and Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward Huey, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Morton A. Kreitchman PET Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01NS076837

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAP4551

Identifier Type: -

Identifier Source: org_study_id