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F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis (T807ALS)

This study is currently recruiting participants.
Verified May 2017 by Tammie Benzinger, Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02414230
First Posted: April 10, 2015
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tammie Benzinger, Washington University School of Medicine
  Purpose
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.

Condition Intervention Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: Drug: F 18 T807 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis (IND 123119 Protocol B)

Resource links provided by NLM:


Further study details as provided by Tammie Benzinger, Washington University School of Medicine:

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. [ Time Frame: 5 years ]

Estimated Enrollment: 20
Study Start Date: February 2015
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental F 18 T807 Drug: 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.
Other Name: Drug: 18F-AV-1451

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414230


Contacts
Contact: Kelley Jackson, BA 314 362 6737 jacksonk@mir.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kelley Jackson    314-362-6737    jacksonk@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Tammie Benzinger, MD, PhD Washington University School of Medicine
  More Information

Responsible Party: Tammie Benzinger, Associate Professor of Radiology and Neurological Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02414230     History of Changes
Other Study ID Numbers: IND 123119 Protocol B
First Submitted: April 7, 2015
First Posted: April 10, 2015
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share the data with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. We may also share this research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If the individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at the information.

Keywords provided by Tammie Benzinger, Washington University School of Medicine:
fronto-temporal dementia
Tauopathies
Nervous System Diseases
Neurodegenerative Diseases

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases