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

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.

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Key information

Conditions

Frontotemporal Lobar Degeneration (FTLD) Brain Diseases Central Nervous System Diseases Dementia Frontotemporal Dementia Frontotemporal Dementia (FTD) Frontotemporal Lobar Degeneration Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies TDP-43 Proteinopathies Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Morton A. Kreitchman PET Center

New York, 10032, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-AV-1451

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.

Other names: [18F]AV-1451

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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Feb 8, 2016
Registry last updated: Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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