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

Primary Purpose

Alzheimer Disease

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
F 18 T807
Sponsored by
Tammie L. S. Benzinger, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Dementia, Brain Diseases, Central Nervous System Diseases, Mild Cognitive Impairment, tauopathies, Neurodegenerative Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental F 18 T807

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 7, 2015
Last Updated
July 8, 2020
Sponsor
Tammie L. S. Benzinger, MD, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT02707978
Brief Title
F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD)
Official Title
F 18 T807 Tau PET Imaging of Frontotemporal Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Problems with contracts .
Study Start Date
September 30, 2017 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tammie L. S. Benzinger, MD, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Dementia, Brain Diseases, Central Nervous System Diseases, Mild Cognitive Impairment, tauopathies, Neurodegenerative Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental F 18 T807
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
F 18 T807
Other Intervention Name(s)
18F-AV-1451
Intervention Description
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.
Primary Outcome Measure Information:
Title
F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participants, at least 18 years of age. Clinically diagnosed with frontotemporal dementia (FTD), or a carrier of a mutation known to cause FTD (with or without symptoms); or a normal control. 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). Pre-menopausal women will have a negative a urine pregnancy test within 24 hours of T807 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 severe chronic back pain might not be able to lie still during the scanning procedures). Is deemed likely unable to perform the imaging procedures for any reason. 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 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. For those electing to undergo the optional lumbar puncture: on anticoagulant of any form prior to lumbar puncture.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammie Benzinger, MD, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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