Plasmapheresis Treatment Study for ALS Patients with Anti-NRIP Autoantibody PALADIN2

What this Trial Is About

Researchers are studying amyotrophic lateral sclerosis ALS patients who have anti-NRIP autoantibodies in their plasma. This trial aims to evaluate the use of plasmapheresis as a treatment to lower these autoantibody levels, which are linked to faster motor decline and higher mortality. The study is a single group design enrolling 20 ALS patients with these antibodies to assess the treatments potential effects and safety. Participants will receive three plasmapheresis courses spaced three months apart to reduce plasma anti-NRIP autoantibody concentrations. After the treatment phase, the study will follow patients for an additional six months to monitor longer-term outcomes. The intervention involves using plasmapheresis devices to remove the harmful autoantibodies from the blood. Throughout the study, participants will undergo serial examinations and assessments to track changes in disease progression and severity. Outcome measures include the ALS Functional Rating Scale-Revised ALSFRS-R at various timepoints up to 15 months, muscle strength tests, walking distance, quality of life scores, respiratory capacity, muscle action potentials, motor unit estimates, and neurofilament levels. Safety is monitored by recording any side effects related to plasmapheresis. The total study duration per participant covers the treatment period plus follow-up assessments.

Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP 2 (PALADIN2)