F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis (IND 123119 Protocol B)

Conditions
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Amyotrophic Lateral Sclerosis (ALS)

Intervention / Treatment
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* Drug: Drug: F 18 T807


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental F 18 T807<br> | Drug: Drug: F 18 T807<br>* 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.<br>* Other names: Drug: 18F-AV-1451;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fronto-temporal dementia, Tauopathies, Nervous System Diseases, Neurodegenerative Diseases