Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations
Overview
- Phase
- Phase 2
- Intervention
- 18F-AV-1451
- Conditions
- Frontotemporal Lobar Degeneration (FTLD)
- Sponsor
- Columbia University
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- SUVR of 18F-AV-1451
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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).
Investigators
Edward D Huey, MD
Assistant Professor of Psychiatry and Neurology
Columbia University
Eligibility 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
Arms & Interventions
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.
Intervention: 18F-AV-1451
Outcomes
Primary Outcomes
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.