What side effects are associated with this type of intervention?

Monoclonal antibody treatments for Multiple System Atrophy, such as those targeting alpha-synuclein, can cause side effects including infusion-related reactions (fever, chills, rash), increased risk of infections, and potential allergic reactions. Specific neurological side effects may also occur depending on the treatment's mechanism of action.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting alpha-synuclein for Multiple System Atrophy (MSA). The management of MSA primarily focuses on symptomatic treatment, including the use of medications like levodopa for motor symptoms, although the response is often poor or unsustained. Other treatments address non-motor symptoms such as orthostatic hypotension, depression, and dystonia. Lu AF82422, a monoclonal antibody targeting alpha-synuclein, represents a novel approach under investigation, aiming to modify disease progression rather than just alleviating symptoms.

What other types of research exist?

Promising novel alternatives to Lu AF82422 for Multiple System Atrophy patients include other monoclonal antibodies targeting alpha-synuclein, small molecule inhibitors, and gene therapies. Specific examples are not provided in the context, but patients should discuss emerging treatments in clinical trials with their healthcare provider.

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Lu AF82422 for Multiple System Atrophy (AMULET Trial)

Phase 2

Waitlist Available

Research Sponsored by H. Lundbeck A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Key

Be older than 18 years old

Must not have

The participant has been treated with an anti-α-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of α-synuclein aggregation within the last 12 months.

The participant has evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA (for example, serious neurological disorder, other intracranial disease, or systemic disease).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new drug called Lu AF82422 to see if it can slow down the progression of multiple system atrophy (MSA). MSA is a rare and worsening neurological condition, and current treatments may not be effective. The study will compare the new drug to determine its effectiveness.

Who is the study for?

This trial is for individuals with multiple system atrophy (MSA) diagnosed within the last 5 years, having motor or autonomic symptoms. They should have a UMSARS Part I score ≤16 and a MoCA score ≥22, indicating certain levels of physical and cognitive function. Participants must be likely to follow the study protocol and not have used other investigational products recently.

What is being tested?

The study tests Lu AF82422's effect on disease progression in MSA patients against a placebo. It aims to understand if this drug can slow down the worsening of symptoms associated with MSA, which includes both parkinsonian (MSA-P) and cerebellar types (MSA-C).

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to Lu AF82422 compared to those receiving a placebo. Side effects could range from mild to severe depending on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been treated with specific Parkinson's disease therapies in the last year.

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I have no significant health issues other than MSA.

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I have never received a vaccine targeting α-synuclein.

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Two or more of my blood relatives have had MSA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Participants in the DBP will receive Lu AF82422 matching placebo IV infusion Q4W from Baseline for a minimum 48 weeks up to a maximum 72 weeks.

Group II: Lu AF82422Experimental Treatment1 Intervention

Participants in the DBP will receive Lu AF82422 intravenous (IV) infusion every 4 weeks (Q4W) from Baseline for a minimum 48 weeks up to a maximum 72 weeks. In the optional OLE, all participants will receive Lu AF82422 IV infusion starting on Day 1 of the OLE up to week 92.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lu AF82422

2018

Completed Phase 1

~80

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple System Atrophy (MSA) focus on managing symptoms and targeting the underlying pathology of the disease. Lu AF82422, a monoclonal antibody targeting alpha-synuclein, aims to reduce the aggregation of this protein, which is a key factor in MSA's neurodegenerative process. By preventing alpha-synuclein accumulation, such treatments may slow disease progression and improve neurological function. Other treatments for MSA include medications to manage autonomic dysfunction, such as blood pressure fluctuations and urinary issues, and drugs like levodopa to alleviate parkinsonian symptoms. These treatments are crucial for improving the quality of life and potentially altering the disease course for MSA patients.

Investigational drugs in Alzheimer's disease: current progress.