Recruiting

Observational Study

Sponsor:

Holy Cross Hospital, Florida

Code:

NCT05309408

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Venipuncture

Lumbar Puncture

Study Details

Brief summary:

Longitudinally collect biomarkers from patients with amyotrophic lateral sclerosis (ALS) and control participants in order to further elucidate both potential causes and treatments for ALS. Samples and clinical information will be collected from patients with ALS and controls.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT05309408

Start date

Jun 11, 2021

Status verified date

Sep, 2023

Completion date

Sep, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

ALS

Patients with Amyotrophic Lateral Sclerosis (ALS)

Control

Participants who do not have chronic neuromuscular diseases or diseases that mimic ALS.

Interventions

Venipuncture

Venipuncture

Lumbar Puncture

Lumbar Puncture

Primary outcome measure

  • Biofluid Biorepository [ Time Frame: + 2.5 Years ] [ Time Frame: 30 months ]

Central Contacts and Locations

Central contacts

Locations

Holy Cross Hospital

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Principal Investigator:

Gustavo Alameda, MD

More Information

Sponsor

Holy Cross Hospital, Florida

Last update posted

Sep 22, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Holy Cross Hospital, Florida on 2023-09-22.