F 18 T807 Tau PET Imaging of Frontotemporal Dementia

Tammie L. S. Benzinger, MD, PhD1 site in 1 countrySeptember 30, 2017

ConditionsAlzheimer Disease

InterventionsF 18 T807

DrugsF 18 T807

Overview

Phase: Phase 2
Intervention: F 18 T807
Conditions: Alzheimer Disease
Sponsor: Tammie L. S. Benzinger, MD, PhD
Locations: 1
Primary Endpoint: F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research study is to evaluate tau distribution in the brain of subjects with: FTD caused by different genetic mutations, any mutation carriers (with or without symptoms), any non-mutation carrier, any sporadic FTD, normal controls.

Registry

clinicaltrials.gov

Start Date

September 30, 2017

End Date

December 30, 2020

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tammie L. S. Benzinger, MD, PhD

Responsible Party

Sponsor Investigator

Principal Investigator

Tammie L. S. Benzinger, MD, PhD

Associate Professor of Radiology and Neurological Surgery

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

•Male or female participants, at least 18 years of age.
•Clinically diagnosed with frontotemporal dementia (FTD), or a carrier of a mutation known to cause FTD (with or without symptoms); or a normal control.
•Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
•Pre-menopausal women will have a negative a urine pregnancy test within 24 hours of T807 drug administration.

Exclusion Criteria

•Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
•Is deemed likely unable to perform the imaging procedures for any reason.
•Has a history of Torsades de Pointes or is taking medications known to prolong QT interval. To determine who will be excluded from this study based on this criterion, we will review participant's medical history and current medications at time of screening. Participants will be excluded from the study if any of the following restricted medications are being taken:
•Disopyramide
•Dofetilide
•Ibutilide
•Procainamide
•Quinidine
•Has hypersensitivity to F 18 T807 or any of its excipients.
•Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.