Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures

Launched by TARGET ALS FOUNDATION, INC. · Nov 16, 2021

Keywords

ClinConnect Summary

The Target ALS Biomarker Study is researching Amyotrophic Lateral Sclerosis (ALS) and aims to collect important biological samples like blood, spinal fluid, and urine from ALS patients and healthy individuals. This study will involve 200 ALS patients and 80 healthy controls over five years. Participants will regularly provide speech samples using a simple app on their smartphones or tablets, and some will also track their lung function from home. This frequent data collection will help researchers better understand how ALS progresses over time.

To join the study, ALS patients need to be at least 18 years old, have a confirmed diagnosis of ALS, and be able to complete certain tests, including a lumbar puncture (a procedure where a small amount of spinal fluid is taken). Healthy participants must also be at least 18 years old and have no neurological diseases. Throughout the study, ALS participants will visit the clinic five times over 20 months, while healthy participants will have two visits over a year. All samples and information collected will be stored safely and used for future research, helping to advance our understanding of ALS.

Gender

ALL

Eligibility criteria

• ALS Participants:
• • 1. Age 18 or older.
• • 2. A diagnosis of ALS in accordance with Gold Coast criteria.
• • 3. 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.
• • 4. Ability to provide informed consent and understand the purpose and risks of the study.
• • 5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.
• Healthy Control Participants:
• • 1. Age 18 or older.
• • 2. No history of neurological disease, in the opinion of the Principal Investigator.
• • 3. No known ALS- associated genetic mutations at the time of consent.
• • 4. Ability to provide informed consent and understand the purpose and risks of the study.
• • 5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.