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

Columbia University

Status and phase: Completed; Phase 2

Conditions: Frontotemporal Lobar Degeneration (FTLD); Frontotemporal Dementia (FTD); Tauopathies

Treatments: Drug: 18F-AV-1451

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02676843

R01NS076837 (U.S. NIH Grant/Contract)

AAAP4551

Details and patient eligibility

About

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.

Full 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).

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

18F-AV-1451

Experimental group

Description:

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.

Treatment:

Drug: 18F-AV-1451