F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis

Study Purpose:

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Active, currently recruiting

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Tammie Benzinger, MD, PhD (Washington University School of Medicine)

Clinicaltrials.gov ID (11 digit #):

NCT02414230

Neals Affiliated?

No

Coordinating Center Contact Information

Washington University School of Medicine
Trish Stevenson; Kelley Jackson / .(JavaScript must be enabled to view this email address) / 314 362-3613; 314 362-6737
.(JavaScript must be enabled to view this email address) St. Louis, Missouri 63110 United States

Full Study Summary:

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.

Study Sponsor:

Washington University School of Medicine

Participant Duration:

Estimated Enrollment:

20

Estimated Study Start Date:

01/31/2015

Estimated Study Completion Date:

02/29/2020

Posting Last Modified Date:

11/02/2016

Date Study Added to alsconsortium.org:

08/19/2015
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    Inclusion Criteria:
    -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.
    -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).
    -Pre-menopausal women will undergo a urine pregnancy test within 24 hours of 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 significant respiratory involvement may not be able to lie flat during the scanning procedures).
    -Is deemed likely unable to perform the imaging procedures for any reason.
    -Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
    -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.

  • Site Contact Information

    Washington University School of Medicine
    St. Louis, Missouri 63110
    United States