F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Interventional Trial
Study Category:Drug Trial
Study Chair(s)/Principal Investigator(s):
Tammie Benzinger, MD, PhD (Washington University School of Medicine)
Clinicaltrials.gov ID (11 digit #):NCT02414230
Coordinating Center Contact InformationWashington University School of Medicine
Full Study Summary:
The purpose of this research study is to evaluate tau distribution in the brain of subjects with: ALS caused by different genetic mutations, any mutation carriers (with or without symptoms), any non-mutation carrier, any sporadic FTD, normal controls.
Study Sponsor:Washington University School of Medicine
Estimated Study Start Date:02/01/2015
Estimated Study Completion Date:09/01/2020
Posting Last Modified Date:01/11/2018
Date Study Added to alsconsortium.org:08/19/2015
Time since Symptom Onset:
Time since Diagnosis:
Can participants use Riluzole?
-Clinically diagnosed with amyotrophic lateral sclerosis (ALS), fronto-temporal dementia (FTD), or both; or a carrier of a mutation known to cause ALS or FTD (with or without symptoms); or a normal control.
-Participant is able and willing to undergo testing (psychometric testing, MRI or CT, PET, radioactive tracer injection; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
-Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.
-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 significant respiratory involvement may not be able to lie flat during the scanning procedures).
-Is deemed likely unable to perform the imaging procedures for any reason.
-Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
-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.
-Currently pregnant or breast-feeding.
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