NCT07774585|Not Yet RecruitingPhase 1
Loading search results
Sponsor study identifier
interventional
3
1 country
1
Study Start
September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2026
Actual (reported)August 19, 2026
Actual (reported)September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence of treatment-emergent adverse events
Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) to study treatment.
From first dose through Week 12
Change from Baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) Total Score (Parts I-IV)
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.
Baseline, Week 4, Week 8, and Week 12
Change from baseline in DAT-PET/MRI measures of striatal dopamine transporter uptake and brain structural changes
Change from baseline in DAT-PET/MRI imaging parameters, including brain metabolic and structural changes.
Baseline and Week 12
Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Baseline, Week 4, Week 8, and Week 12
Change in Patient Global Impression of Improvement (PGI-I) Score
Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Mini-Mental State Examination (MMSE) Score
Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Hamilton Depression Rating Scale (HAMD) Score
Baseline, Week 4, Week 8, and Week 12
Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score
Baseline, Week 4, Week 8, and Week 12
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
Shanghai, Shanghai Municipality, 200025, China
First Submitted
May 12, 2026
First Posted
August 19, 2026
Study Start
September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2026
EstimatedExpansion Study of ALT001 in Patients With Multiple System Atrophy
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 19, 2026
Record last verified: 2026-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: