F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD) | NCT02707978

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

NCT02707978

Sponsor

Tammie L. S. Benzinger, MD, PhD

Status

Withdrawn

Last Update Posted

Mar 13, 2024Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Alzheimer Disease

Interventions

F 18 T807

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Problems with contracts .

Expanded Access Info

Start Date

Sep 30, 2017Estimated

Primary Completion Date

Sep 30, 2020Actual

Completion Date

Dec 30, 2020Actual

First Submitted Date

Apr 7, 2015

First Submission Date that Met QC Criteria

Mar 8, 2016

First Posted Date

Mar 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2024

Last Update Posted Date

Mar 13, 2024Actual

Label	Type	Description	Intervention Names
Experimental F 18 T807	Experimental		Drug: F 18 T807

Name	Type	Description	Arm Group Labels	Other Names
F 18 T807	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.

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000544	Alzheimer Disease
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D060825	Cognitive Dysfunction
D024801	Tauopathies
D019636	Neurodegenerative Diseases

ID	Term
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D003072	Cognition Disorders