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

Primary Purpose

Frontotemporal Lobar Degeneration (FTLD), Frontotemporal Dementia (FTD), Tauopathies

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

18F-AV-1451

About this trial

This is an interventional diagnostic trial for Frontotemporal Lobar Degeneration (FTLD) focused on measuring FTLD, FTD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Morton A. Kreitchman PET Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-AV-1451

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02676843

First Posted

January 15, 2016

Last Updated

November 18, 2019

Sponsor

Columbia University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT02676843

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

April 2016 (Actual)

Primary Completion Date

November 25, 2018 (Actual)

Study Completion Date

November 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Frontotemporal Lobar Degeneration (FTLD), Frontotemporal Dementia (FTD), Tauopathies

Keywords

FTLD, FTD

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

18F-AV-1451

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

18F-AV-1451

Other Intervention Name(s)

[18F]AV-1451

Intervention Description

A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.

Primary Outcome Measure Information:

Title

SUVR of 18F-AV-1451

Description

Time Frame

Baseline, 12-month follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward Huey, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Morton A. Kreitchman PET Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified clinical characteristics subjects such as age, mutation and rating scale/score of mental state in the manuscript.

IPD Sharing Time Frame

Availability of the manuscript through journal editors

IPD Sharing Access Criteria

Availability of the manuscript through journal editors

Learn more about this trial

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

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