Status:
UNKNOWN
A Longitudinal Analysis of Biomarkers in Patients With ALS
Lead Sponsor:
Holy Cross Hospital, Florida
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
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 an...
Detailed Description
The objective of the proposed study is to longitudinally collect biomarkers from patients with amyotrophic lateral sclerosis (ALS) and control participants in order to further elucidate both potential...
Eligibility Criteria
Inclusion
- 18 years of age or older at time of consent.
- Capable of providing informed consent.
- Capable of complying with study procedures.
- 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)
- 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
- Lumbar Puncture volunteers only: Clinically appropriate to have a lumbar puncture
Exclusion
- Presence of a neurodegenerative disease other than ALS
- Clinically significant history of unstable medical illness
- Inability to comply with study procedures, in the view of the investigator
- 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
- 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)
- Taking any immunomodulatory or immunosuppressive medication, as determined by the principal investigator.
Key Trial Info
Start Date :
June 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05309408
Start Date
June 11 2021
End Date
September 1 2024
Last Update
September 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308