Collecting biomarkers from ALS patients and controls

A Longitudinal Analysis of Biomarkers in Patients With ALS

This study is trying to collect and analyze different body fluids from people with ALS and healthy individuals over 30 months to better understand the disease and find new treatments.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Holy Cross Hospital, Florida (Academic / other)
• Locations: 1 site (Fort Lauderdale, Florida)
• Trial ID: NCT05309408 on ClinicalTrials.gov

What this trial studies

This study aims to longitudinally collect and analyze biomarkers from patients diagnosed with amyotrophic lateral sclerosis (ALS) and control participants without neurodegenerative diseases. Researchers will gather various biofluids, including blood, urine, and cerebrospinal fluid (CSF), to explore potential causes and treatments for ALS. The study will involve multiple visits over a period of up to 30 months, allowing for in-depth analysis of immune cell populations, gene expression, and other clinical parameters. Excess samples will be stored for future research at the Massachusetts General Hospital ALS Sample Repository.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of familial or sporadic ALS, as well as healthy controls without neurodegenerative diseases.

Not a fit: Patients with other neurodegenerative diseases or significant medical illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of ALS and lead to improved diagnostic and therapeutic strategies.

How similar studies have performed: Other studies have shown promise in using biomarker analysis for neurodegenerative diseases, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. 18 years of age or older at time of consent.
2. Capable of providing informed consent.
3. Capable of complying with study procedures.
4. ALS Subjects only: ALS subjects diagnosed with familial or sporadic ALS as according to the El Escorial Criteria (suspected, possible, probable - lab supported, probable, or definite) or individuals with known gene mutations associated with ALS (regardless of clinical phenotype)
5. Control Subjects only: Absence of autoimmune myopathy, neuropathy, ALS mimic disorder, or any other neurodegenerative disease or known diagnosis of ALS, or known ALS causative gene
6. Lumbar Puncture volunteers only: Clinically appropriate to have a lumbar puncture

Exclusion Criteria:

1. Presence of a neurodegenerative disease other than ALS
2. Clinically significant history of unstable medical illness
3. Inability to comply with study procedures, in the view of the investigator
4. Lumbar Puncture volunteers only: Presence of bleeding disorder, problems with cerebrospinal fluid pressure, allergy to local anesthetics, a topical or other skin infection at the lumbar puncture site
5. Lumbar Puncture volunteers only: Taking an anti-platelet or anticoagulant drug, such as Plavix, Brilinta, Ticlid, Warfarin/Coumadin, Lovenox, Elaquis, Pradaxa, Xarelto, etc, and unable to safely hold it for this study. (Aspirin is allowed)
6. Taking any immunomodulatory or immunosuppressive medication, as determined by the principal investigator.

Where this trial is running

Fort Lauderdale, Florida

• Holy Cross Hospital — Fort Lauderdale, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Ashley Stepler

Conditions Amyotrophic Lateral Sclerosis