F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD)

NCT ID: NCT02707978

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2020-12-30

Brief 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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental F 18 T807

Group Type: EXPERIMENTAL

F 18 T807

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

18F-AV-1451

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tammie L. S. Benzinger, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Tammie L. S. Benzinger, MD, PhD

Associate Professor of Radiology and Neurological Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tammie Benzinger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

IND 123119 Protocol C

Identifier Type: -

Identifier Source: org_study_id