A Prospective Exploratory Study of the Safety and Preliminary Efficacy of the α-Syn H21 Monoclonal Antibody in Patients With Multiple System Atrophy

A Prospective Exploratory Study of the Safety and Preliminary Efficacy of the α-Syn H21 Monoclonal Antibody in Patients With Multiple System Atrophy

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.

Inclusion Criteria:

• 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
• Able to comply with study procedures and follow-up assessments
• Mini-Mental State Examination (MMSE) score not consistent with significant dementia
• Willing and able to provide written informed consent

Exclusion Criteria:

• 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
• Women or men unwilling to use effective contraception during the study
• Participation in another clinical trial or receipt of investigational treatment within 3 months before enrollment
• Any other condition that, in the investigator's judgment, would make participation inappropriate