Multiple system atrophy (MSA) is a progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar ataxia. Abnormal aggregation of alpha-synuclein is believed to play an important role in disease progression. The α-Syn H21 monoclonal antibody is designed to selectively bind pathological alpha-synuclein aggregates and may reduce their spread and related neuroinflammation.
This single-center, prospective, exploratory study will evaluate the safety, tolerability, and preliminary efficacy of the α-Syn H21 monoclonal antibody in patients with MSA. Participants will receive intravenous infusions of H21 every 4 weeks for 3 doses and will be followed for 12 weeks. Clinical symptoms, laboratory tests, imaging findings, and adverse events will be assessed to determine whether H21 may provide clinical benefit and support future larger studies.
Age 45 to 75 years, male or female
Diagnosis of Multiple System Atrophy meeting current clinical diagnostic criteria for probable or possible MSA
Disease duration of 2 years or less from onset of motor or autonomic symptoms
Clinically stable disease without significant fluctuation or acute worsening within 4 weeks before enrollment
History or presence of other neurological disorders that may interfere with study assessments, including Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, or stroke
Severe cognitive impairment or psychiatric disorder, including clinically significant depression or anxiety
Severe cardiac, hepatic, renal, or other major systemic disease
History of severe hypersensitivity to monoclonal antibody therapies Pregnant or breastfeeding women