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

Phase 2

Completed

• Conditions: Frontotemporal Lobar Degeneration (FTLD); Frontotemporal Dementia (FTD); Tauopathies
• Interventions: Drug: 18F-AV-1451

• Registration Number: NCT02676843
• Lead Sponsor: 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.

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).

Study Timeline

• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-08
• Study Start: 2016-04
• Primary Completion: 2018-11-25
• Study Completion: 2018-11-25
• Status Verified: 2019-11
• Results First Submitted: 2019-11-18
• Results First Submitted QC: 2019-11-18
• Last Update Submitted: 2019-11-18
• Results First Posted: 2019-12-06
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-AV-1451	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.

Primary Outcome Measures

Name	Time	Method
SUVR of 18F-AV-1451	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.

Trial Locations

Locations (1)

Morton A. Kreitchman PET Center; 🇺🇸 New York, New York, United States