Can an antibody clear the toxic clumps behind a rare brain disease?

NCT ID NCT07774585

Registered, but not yet taking participants.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This early-stage trial tests whether an experimental antibody called α-Syn H21 is safe and might help people with multiple system atrophy (MSA), a rare and progressive brain disorder. The antibody is designed to latch onto and neutralize abnormal clumps of a protein called alpha-synuclein, which are thought to drive the disease. Three adults with MSA will receive the antibody by infusion every four weeks for three doses, and researchers will track side effects, symptom changes, and brain imaging over 12 weeks to see if the approach shows promise for larger studies.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
α-Syn H21 monoclonal antibody, given by intravenous infusion every 4 weeks for 3 doses
What this could lead to
If safe and effective, this antibody could slow or halt the progression of multiple system atrophy, a currently untreatable neurodegenerative disease.
What could go wrong
This is a very early, small study (only 3 participants) focused on safety, so it may not show clear benefit. The antibody could also cause infusion reactions or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 3 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025

    Shanghai, Shanghai Municipality, 200025, China

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