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

Tauopathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676843
• Other study ID #: AAAP4551
• Secondary ID: R01NS076837
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: November 25, 2018

Study information

• Verified date: November 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 25, 2018
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Frontotemporal Dementia (FTD)
• Frontotemporal Lobar Degeneration
• Frontotemporal Lobar Degeneration (FTLD)
• Pick Disease of the Brain
• Tauopathies

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Morton A. Kreitchman PET Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUVR of 18F-AV-1451	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.	Baseline, 12-month follow up