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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02707978
Other study ID # IND 123119 Protocol C
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date September 30, 2017
Est. completion date December 30, 2020

Study information

Verified date March 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or female participants, at least 18 years of age. 2. Clinically diagnosed with frontotemporal dementia (FTD), or a carrier of a mutation known to cause FTD (with or without symptoms); or a normal control. 3. 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). 4. Pre-menopausal women will have a negative a urine pregnancy test within 24 hours of T807 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 severe chronic back pain might not be able to lie still during the scanning procedures). 2. Is deemed likely unable to perform the imaging procedures for any reason. 3. 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 - Sotalol - Bepridil 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. 8. For those electing to undergo the optional lumbar puncture: on anticoagulant of any form prior to lumbar puncture.

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Tammie L. S. Benzinger, MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance. 5 years
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