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F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02414230
Acronym
T807ALS
Enrollment
9
Registered
2015-04-10
Start date
2015-02-28
Completion date
2020-06-10
Last updated
2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

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

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.

Interventions

DRUGDrug: F 18 T807

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.

Sponsors

Tammie L. S. Benzinger, MD, PhD
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male or female participants, at least 18 years of age. 2. 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. 3. 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). 4. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.

Exclusion criteria

1. 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). 2. Is deemed likely unable to perform the imaging procedures for any reason. 3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval. 4. Has hypersensitivity to F 18 T807 or any of its excipients. 5. 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. 6. Severe claustrophobia. 7. Currently pregnant or breast-feeding.

Design outcomes

Primary

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026