F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis

NCT02414230 | Completed

• 1 other identifier: IND 123119 Protocol B
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

fronto-temporal dementia; Tauopathies; Nervous System Diseases; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (1)

• F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.

  5 years

Study Arms (1)

Experimental F 18 T807

Drug: Drug: F 18 T807

Interventions

Drug: F 18 T807 DRUG

Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.

Also known as: Drug: 18F-AV-1451

Experimental F 18 T807

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Collaborating neuromuscular physicians will refer participants for MR and PET imaging to evaluate tau distribution in the brain of subjects with ALS, or ALS with frontotemporal dementia caused by different genetic mutations, or any mutation carrier (with or without symptoms), or normal controls.

You may qualify if:

• Male or female participants, at least 18 years of age.
• 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.

You may not qualify if:

• 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.
• Severe claustrophobia.
• Currently pregnant or breast-feeding.

Sponsors & Collaborators

• Tammie L. S. Benzinger, MD, PhD: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Ly CV, Koenig L, Christensen J, Gordon B, Beaumont H, Dahiya S, Chen J, Su Y, Nelson B, Jockel-Balsarotti J, Drain C, Jerome G, Morris JC, Fagan AM, Harms MB, Benzinger TLS, Miller TM, Ances BM. Tau positron emission tomography imaging in C9orf72 repeat expansion carriers. Eur J Neurol. 2019 Sep;26(9):1235-1239. doi: 10.1111/ene.13940. Epub 2019 Mar 25.

  PMID: 30790403 RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Tauopathies; Nervous System Diseases; Neurodegenerative Diseases

Interventions

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

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tammie Benzinger, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology and Neurological Surgery

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 10, 2015
• Study Start: February 1, 2015
• Primary Completion: September 19, 2016
• Study Completion: June 10, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)