Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02559869
• Date of registration: 23/09/2015
• Prospective Registration: Yes
• Primary sponsor: Massachusetts General Hospital
• Public title: Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis TRACK-ALS
• Scientific title: Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
• Date of first enrolment: November 2015
• Target sample size: 86
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02559869
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Suma Babu, MD
• Affiliation: Massachusetts General Hospital

• Name: Joseph Masdeu, MD, PhD
• Affiliation: Houston Methodist Neurological Institute

Key inclusion & exclusion criteria

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

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

1. History of a cardiac pacemaker or pacemaker wires

2. Metallic particles in the body

3. Vascular clips in the head

4. Prosthetic heart valves

5. Claustrophobia

2. Diagnosis of Parkinson's disease or Alzheimer's disease

3. Diagnosis of renal failure

4. Have active or chronic autoimmune disease (such as hepatitis or HIV), infection, or
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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis (ALS)

Intervention(s)

Drug: [18F] GE-180

Primary Outcome(s)

Measure & localize brain inflammation in people with ALS via [18F] GE-180 PET imaging. [Time Frame: 12 months]

Determine systemic inflammatory factors that may modify the progression or other clinical or imaging correlates of ALS. [Time Frame: 12 months]

Define anatomical, structural, and functional changes in the brain via MRI of ALS Subjects vs. Healthy Controls at Baseline [Time Frame: 12 months]

Secondary Outcome(s)

Determine the longitudinal changes in the anatomical, structural, and functional measures in people with ALS, and build ALS prediction models using the clinical and MRI data. [Time Frame: 12 months]

Determine the longitudinal changes in brain inflammation in people with ALS in correlation with ALS severity and rate of progression. [Time Frame: 12 months]

Secondary ID(s)

2015P000140

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Methodist Hospital System

ALS Association

Cedars-Sinai Medical Center