Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures
Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At - Home Measures
Target ALS Foundation, Inc.
1,000 participants
Jun 1, 2021
OBSERVATIONAL
Conditions
Summary
The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amyotrophic Lateral Sclerosis (ALS) patients and 200 healthy controls from sites globally, over a 5 year time frame. Additionally, speech and motor function and spirometry measures will be collected bi-weekly in a subset of participants. ALS participants will be asked to come to the clinic for 5 study visits approximately every 4 months. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies.
Eligibility
Inclusion Criteria12
- ALS Participants:
- Age 18 or older.
- A diagnosis of ALS in accordance with Gold Coast criteria.
- Full Vital Capacity (FVC) of ≥30% or at the discretion of the Principal Investigator for the participant's predicted value for gender, height, and age at the time of screening.
- Ability to provide informed consent and understand the purpose and risks of the study.
- Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.
- Healthy Control Participants:
- Age 18 or older.
- No history of neurological disease, in the opinion of the Principal Investigator.
- No known ALS- associated genetic mutations at the time of consent.
- Ability to provide informed consent and understand the purpose and risks of the study.
- Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05137665