Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis (TRACK-ALS)

Study Purpose:

The goal is to identify imaging biomarkers in people with ALS to expand the understating of ALS pathology, treatment targets, disease progression, and anatomical differences between different disease phenotypes.

Disease:

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

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Active, currently recruiting

Phase:

Not Applicable

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

Nazem Atassi, MD, MMSc —Principal Investigator (Massachusetts General Hospital)
Joseph Masdeu, MD, PhD —Co-Principal Investigator (Methodist Neurological Institute)
Stanley Annel, MD —Co-Principal Investigator (Methodist Neurological Institute)
Clive Svendsen, PhD —Co-Principal Investigator (Cedars-Sinai Medical Center)

Clinicaltrials.gov ID (11 digit #):

NCT02559869

Neals Affiliated?

Yes

Coordinating Center Contact Information

Massachusetts General Hospital NCRI
Catherine Gladden / .(JavaScript must be enabled to view this email address) / 617-724-5456
Lindsay Pothier / .(JavaScript must be enabled to view this email address) / 617-643-5582
165 Cambridge Street
Boston, Massachusetts 02114 United States

Full Study Summary:

This is a multicenter, 18-month study, which aims to identify imaging and biofluid biomarkers in people with ALS to expand the understanding of ALS pathology, treatment targets, disease progression, and anatomical differences between different disease phenotypes. This pilot project is tailored to produce imaging tools that will allow researchers to conduct future ALS clinical trials more efficiently which may in turn impact the pace for ALS drug discovery.

In this trial, approximately 200 subjects will be screened and 100 enrolled in this study from 2 Northeast ALS Consortium (NEALS) centers in the United States. Fifty (50) ALS participants will be age and gender matched to 50 participants with no known neurological disorder (healthy controls). Of these, twenty five (25) ALS participants will be age, (±5 years) gender and binding affinity (TSPO) matched to 25 healthy controls.

Study Sponsor:

ALS finding a cure (ALSA), ALS Association

Participant Duration:

18 Months with follow-up every 3 months thereafter

Estimated Enrollment:

200

Estimated Study Start Date:

11/01/2015

Estimated Study Completion Date:

05/30/2018

Posting Last Modified Date:

07/12/2017

Date Study Added to alsconsortium.org:

08/16/2015
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:
    Study subjects meeting all of the following criteria will be allowed to enroll in the study:
    1. Male or female, aged 18 to 80
    2. Medically safe to undergo MRI scans
    3. Able to safely lie supine for at least 90 minutes in the opinion of the Site Investigator
    4. Capable of providing informed consent and following trial procedures
    5. Geographically accessible to the site

    ALS subjects must also meet the following criteria:
    1. Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by modified El Escorial criteria
    2. ALS Cognitive Behavioral Screen score >10 on the cognitive scale and/or >32 on the behavioral scale

    Those ALS subjects participating in the optional lumbar puncture portion of the study must also meet the following criteria:
    1. Subjects medically able to undergo lumbar puncture (LP) as determined by the investigator (i.e., no bleeding disorder, allergy to local anesthetics, a skin infection at or near the LP site, or evidence of high intracranial pressure).

    For those subjects participating in the PET scan portion of the study, subjects must also meet the following criteria:
    1. Medically safe to undergo PET scans
    2. No prior radiation exposure that exceeds the site™s current guidelines
    3. No known allergy to any components of the tracer
    4. Baseline ECG values are within normal range
    5. Subjects must meet main study entry criteria

    Subject Exclusion Criteria:
    Study subjects meeting any of the following criteria during screening evaluations will be excluded from entry into the study:
    1. Any contraindication to undergo MRI studies such as
    a. History of a cardiac pacemaker or pacemaker wires
    b. Metallic particles in the body
    c. Vascular clips in the head
    d. Prosthetic heart valves
    e. Claustrophobia
    2. Diagnosis of Parkinson™s disease or Alzheimer™s disease
    3. Diagnosis of renal failure
    4. Taking immunosuppressive medications such as steroids, cyclophosphamide, etc.
    5. Presence of diaphragm pacing system (DPS)
    6. The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, according to SI judgment
    7. Pregnant women or women currently breastfeeding
    8. Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject™s full compliance with or completion of the study

    In addition, any subject meeting any of the following criteria during screening evaluations will be excluded from entry into the PET portion of the study:
    1. Radiation exposure that exceeds the site™s current guidelines
    2. Low affinity TSPO binders determined by having a Thr/Thr polymorphism in the TSPO gene (rs6971) at the Screening Visit

    Women of Childbearing Potential (WOCBP) For the purposes of this study, women of child bearing potential are defined as all women who are capable of becoming pregnant, unless they meet one of the following criteria:
    • 12-months post-menopausal
    • Post-hysterectomy
    • Surgically sterile

    If a female subject does not meet these criteria and is considered of child bearing potential they will have a urine or serum pregnancy test performed STAT during any visit at which an MRI scan, PET scan or lumbar puncture is done, immediately prior to the MRI and/or PET scan. Subjects with a positive pregnancy test will be excluded.

  • Site Contact Information

    Houston Methodist Hospita
    Jennifer Garrett RN (Site Research Nurse) / .(JavaScript must be enabled to view this email address) / 713-441-9484
    Luis Lay / .(JavaScript must be enabled to view this email address) / 713-441-3057
    6565 Fannin Street
    Houston, Texas 77030
    United States

    Massachusetts General Hospital
    Beverly Reynolds / .(JavaScript must be enabled to view this email address) / 617-643-2522
    Paul Cernasov / .(JavaScript must be enabled to view this email address) / 17-726-1880
    55 Fruit Street
    Boston, Massachusetts 02114
    United States