LM11A-31 for Progressive Supranuclear Palsy

PR
Overseen ByPTP Recruitment and Retention (RER) Team
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called LM11A-31, an experimental therapy for Progressive Supranuclear Palsy (PSP), a brain disorder affecting movement and balance. The main goal is to determine if this treatment is safe and effective for managing PSP symptoms. Participants will receive either the LM11A-31 treatment or a placebo, which is a non-active substance. Eligible participants must have experienced PSP symptoms for five years or less and be able to walk at least 10 steps with minimal assistance. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LM11A-31 has undergone studies for its safety in humans. While specific side effects remain unspecified, its progression to a clinical trial indicates a demonstrated level of safety in earlier research. Reaching this stage typically suggests it was deemed fairly safe in smaller, prior studies. This trial aims to further assess its safety and effectiveness for progressive supranuclear palsy (PSP), a condition affecting movement and balance. Researchers will closely monitor participants for any side effects throughout the trial.12345

Why do researchers think this study treatment might be promising?

Most treatments for Progressive Supranuclear Palsy (PSP) focus on managing symptoms, often using medications like levodopa or amantadine that target neurotransmitter imbalances. However, LM11A-31 works differently by targeting the neurotrophic pathways, which are crucial for neuron survival and function. This treatment has the potential to slow down the progression of the disease rather than just alleviate symptoms. Researchers are excited because LM11A-31 could offer a novel approach to modifying the disease process, providing hope for longer-term benefits in PSP management.

What evidence suggests that LM11A-31 might be an effective treatment for PSP?

Research has shown that LM11A-31, which participants in this trial may receive, may help treat brain diseases. In studies on Alzheimer's disease, LM11A-31 improved several signs of the disease, suggesting it might also help with Progressive Supranuclear Palsy (PSP). The drug targets a specific part of the brain, potentially protecting nerve cells from harm. Early results also suggest it could slow the disease's progression, which is important for PSP patients.678910

Who Is on the Research Team?

AW

Anne-Marie Wills, MD

Principal Investigator

Massachusetts General Hospital

AB

Adam Boxer, MD, PhD

Principal Investigator

University of California, San Francisco

IL

Irene Litvan, MD

Principal Investigator

University of California, San Diego

JR

Julio Rojas-Martinez, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for people diagnosed with possible or probable Progressive Supranuclear Palsy (PSP) Richardson's Syndrome, who have had symptoms for 5 years or less. Participants must be able to walk at least 10 steps with minimal help, live at home or in the community, and have good enough vision, hearing, and thinking skills to take part.

Inclusion Criteria

My mental state score is 25 or higher.
I have been diagnosed with possible or probable PSP Richardson's Syndrome.
I live at home or in a community setting, including assisted living.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment before randomization

1 week

Treatment

Participants receive either active LM11A-31 or matching placebo for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LM11A-31

Trial Overview

The study is testing a new drug called LM11A-31 compared to a placebo (inactive pill) in people with PSP. The goal is to see if LM11A-31 is safe and effective. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Regimen B: LM11A-31Experimental Treatment1 Intervention
Group II: Matching PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adam Boxer

Lead Sponsor

Trials
2
Recruited
50+

Alzheimer's Therapeutic Research Institute

Collaborator

Trials
18
Recruited
58,400+

PharmatrophiX Inc.

Industry Sponsor

Trials
1
Recruited
240+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

University of Southern California

Collaborator

Trials
956
Recruited
1,609,000+

University of California, San Diego

Collaborator

Trials
1,215
Recruited
1,593,000+

Alzheimer's Clinical Trials Consortium

Collaborator

Trials
5
Recruited
2,800+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

NCT07264283 | The Progressive Supranuclear Palsy ...

Regimen B will evaluate the safety and efficacy of a single study drug, LM11A-31, in participants with PSP. Detailed Description. The Progressive Supranuclear ...

LM11A-31 in Alzheimer Disease and PSP

In a phase 2a study that assessed 242 patients with mild-to-moderate Alzheimer's disease, LM11A-31 showed benefits across five biomarker ...

Progressive Supranuclear Palsy Clinical Trial Platform

Regimen B will evaluate the safety and efficacy of a single study drug, LM11A-31, in participants with PSP.

LM11A-31-BHS

The primary outcome is change in disease severity on the 15-item modified Progressive Supranuclear Palsy Rating Scale after one year.

Milestones in Synaptic Defense and Tau Research

LM11A-31 has demonstrated incredible promise with early-stage data showing significant disease-modifying effects as indicated by a wide range ...

Research Studies: Progressive Supranuclear Palsy

The study will collect detailed clinical information, biofluids, and imaging data from individuals with corticobasal degeneration and progressive supranuclear ...

Clinical Characteristics of Progressive Supranuclear Palsy ...

Progressive supranuclear palsy (PSP) may show concomitant neuropathological findings such as Alzheimer's disease (AD)‐related pathologies.

Environmental Risk Factors for Progressive Supranuclear ...

Typically, progressive supranuclear palsy (PSP) is clinically characterized by vertical slowing of saccades or supranuclear gaze palsy, axial-predominant ...

Progressive supranuclear palsy – clinical trials

Progressive supranuclear palsy. Recruiting. A study to evaluate the safety and effectiveness of NIO752 in patients with progressive supranuclear palsy.

The Progressive Supranuclear Palsy Clinical Trial Platform

The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is a multi-center, multi-regimen clinical trial evaluating the safety and efficacy of ...