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

NCT02676843 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: AAAP4551R01NS076837
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

FTLD; FTD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

18F-AV-1451

EXPERIMENTAL

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.

Drug: 18F-AV-1451

Interventions

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.

Also known as: [18F]AV-1451

18F-AV-1451

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unwillingness to participate
• Usage of medication which significantly prolongs QT interval
• Pregnancy or plans for pregnancy within 90 days after participating in study

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Morton A. Kreitchman PET Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Frontotemporal Lobar Degeneration; Frontotemporal Dementia; Tauopathies

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: William Kreisl, MD
• Organization: Columbia University

wck2107@cumc.columbia.edu

212-342-2380

Study Officials

• Edward Huey, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Neurology

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: February 8, 2016
• Study Start: April 1, 2016
• Primary Completion: November 25, 2018
• Study Completion: November 25, 2018
• Last Updated: December 6, 2019
• Results First Posted: December 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Availability of the manuscript through journal editors
• Access Criteria: Availability of the manuscript through journal editors

Locations

US (1)