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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTarget ALS Foundation, Inc.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups

Sponsors and collaborators