α-Syn H21 Monoclonal Antibody: The α-Syn H21 monoclonal antibody is a humanized monoclonal antibody designed to selectively bind pathological alpha-synuclein aggregates. Participants will receive the study drug by intravenous infusion once every 4 weeks for a total of 3 doses during the 12-week study period.
Study summary
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.
Eligibility
Sex
ALL
Min age
45 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of treatment-emergent adverse events — From first dose through Week 12 Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) to study treatment.
Change from Baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) Total Score (Parts I-IV) — Baseline, Week 4, Week 8, and Week 12 Change from baseline in the total score and subscale scores of the Unified Multiple System Atrophy Rating Scale (UMSARS Parts I-IV). The UMSARS is a clinician-administered scale used to assess disease severity in patients with multiple system atrophy. Total scores are derived from Parts I-IV, with higher scores indicating greater disease severity and worse clinical status. The total score ranges from 0 to 249, with higher scores indicating more severe impairment.
Change from baseline in DAT-PET/MRI measures of striatal dopamine transporter uptake and brain structural changes — Baseline and Week 12 Change from baseline in DAT-PET/MRI imaging parameters, including brain metabolic and structural changes.
Trial sites (1)
Facility
City
Region
Status
Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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