NEU-411 for Parkinson's Disease

(NEULARK Trial)

Recruiting at 67 trial locations

Overseen By Sam Jackson, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Neuron23 Inc.

Disqualifiers: Secondary parkinsonian syndromes, uncontrolled diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 52 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new drug, NEU-411, for individuals with early Parkinson's Disease who possess a specific genetic trait. The researchers aim to determine if NEU-411 can manage symptoms and ensure its safety. Participants will take either NEU-411 or a placebo (a pill with no active medicine) daily for a year. This trial suits individuals diagnosed with Parkinson's Disease who have a genetic marker linked to the LRRK2 pathway, a specific part of their genetic makeup. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that NEU-411 is likely to be safe for humans?

Research has shown that NEU-411 underwent testing in earlier studies with healthy volunteers. These studies examined how the treatment is processed in the body and its initial safety. NEU-411 targets a specific brain pathway linked to Parkinson's disease.

In those trials, NEU-411 was generally well-tolerated. Some participants experienced mild side effects, such as headaches or stomach upset, but these were not severe. This suggests that NEU-411 could be safe for further testing in people with Parkinson's. However, since research is ongoing, the complete safety profile for Parkinson's patients is still being determined.

NEU-411 is now in a testing phase that focuses more on safety in a specific patient group. Researchers are closely observing how NEU-411 works in people with early Parkinson's and are carefully monitoring any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Unlike the standard Parkinson's treatments, which typically include medications like levodopa or dopamine agonists, NEU-411 acts through a novel mechanism, potentially offering benefits that existing therapies don't provide. While current options mainly focus on replenishing dopamine levels or mimicking its effects, NEU-411 might work differently by targeting alternative neural pathways involved in Parkinson’s symptoms. Researchers are excited about NEU-411 because it could offer improved symptom management and possibly fewer side effects, making it a promising new option for patients.

What evidence suggests that NEU-411 might be an effective treatment for Parkinson's Disease?

Research has shown that NEU-411, which participants in this trial may receive, could be a promising treatment for Parkinson's Disease, particularly for individuals with high activity in the LRRK2 pathway of their cells. NEU-411 blocks this pathway, which may contribute to the progression of Parkinson's. Early studies in healthy individuals have demonstrated that NEU-411 is safe and well-tolerated. While researchers continue to gather detailed information on its effectiveness in Parkinson's patients, the treatment aims to slow the disease by addressing one of its underlying causes. This approach offers hope for a new way to manage early Parkinson's Disease. ^{1 2 5 6 7}

Who Is on the Research Team?

Fatta B Nahab, MD, FAAN FANA

Principal Investigator

Neuron23 Inc.

Are You a Good Fit for This Trial?

This trial is for men and women aged 50-80 with early Parkinson's Disease, who have a certain genetic profile indicating high activity in the LRRK2 pathway. They must be diagnosed with PD and have a disease severity score (mH&Y) of 1 to 2.5.

Inclusion Criteria

I am between 50 and 80 years old.

My Parkinson's is linked to the LRRK2 gene according to a specific test.

My Parkinson's disease is in the early to mid-stage.

Exclusion Criteria

I don't have any major health issues apart from my current condition.

My condition is a type of parkinsonism that's not typical Parkinson's disease.

My diabetes is not under control, with HbA1c over 8%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NEU-411 or placebo daily for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NEU-411

Trial Overview The study tests NEU-411 against a placebo over the course of one year to see if it's effective and safe for treating early-stage Parkinson's Disease in patients with specific genetic markers.

How Is the Trial Designed?

Group I: NEU-411 Experimental Treatment 1 Intervention

Orally-administered NEU-411

Group II: Placebo Placebo Group 1 Intervention

Orally-administered matching placebo

Who Is Running the Clinical Trial?

Neuron23 Inc.

Lead Sponsor

Trials

6

Recruited

560+

Qiagen Manchester Limited

Collaborator

Roche Diagnostic Ltd.

Industry Sponsor

Trials

13

Recruited

47,800+

Published Research Related to This Trial

The long-term use of the rotigotine transdermal system in early Parkinson's disease was generally well tolerated over a median exposure of approximately 5 years, with adverse events similar to those seen in shorter studies.

Despite some patients experiencing adverse events leading to withdrawal, only 24% discontinued the treatment, and the mean scores on the Unified Parkinson's Disease Rating Scale remained stable for up to 2 years, indicating sustained efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: a prospective, open-label extension study. Elmer, LW., Surmann, E., Boroojerdi, B., et al.[2018]

In a study involving 16 patients with moderate Parkinson's disease, the NR2B-selective NMDA receptor antagonist MK-0657 did not show significant improvement in motor function compared to placebo, despite achieving the target plasma concentration.

While MK-0657 was generally well tolerated, it did lead to increases in blood pressure, indicating potential safety concerns that may limit its use in treating Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose administration of MK-0657, an NR2B-selective NMDA antagonist, does not result in clinically meaningful improvement in motor function in patients with moderate Parkinson's disease. Addy, C., Assaid, C., Hreniuk, D., et al.[2013]

The Phase I clinical trial of PF-06669571, a novel dopamine D1 receptor partial agonist, demonstrated that the drug was safe and well tolerated in 20 subjects with Parkinson's disease, with no serious safety concerns reported.

Although the primary endpoint for significant improvement in motor symptoms did not meet pre-specified criteria, a sensitivity analysis suggested potential efficacy, particularly when excluding an outlier with a very high L-DOPA dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. Gurrell, R., Duvvuri, S., Sun, P., et al.[2018]

In a study involving 22 Parkinson's disease patients, a single dose of the NR2B antagonist MK-0657 (7 mg) did not significantly reduce levodopa-induced dyskinesias or improve motor symptoms, indicating it may not be an effective treatment for these issues.

Despite achieving the target plasma concentration of the drug, MK-0657 showed no meaningful impact on dyskinesia or motor function as measured by established scales, suggesting that further research is needed to explore effective treatments for levodopa-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase Ib Randomized Controlled Study to Evaluate the Effectiveness of a Single-Dose of the NR2B Selective N-Methyl-D-Aspartate Antagonist MK-0657 on Levodopa-Induced Dyskinesias and Motor Symptoms in Patients With Parkinson Disease. Herring, WJ., Assaid, C., Budd, K., et al.[2018]

In a study involving 139 patients with early Parkinson's disease, the partial dopamine agonist pardoprunox significantly improved motor function, as measured by the Unified PD Rating Scale (UPDRS)-Motor score, compared to placebo, with a mean improvement of -7.3 points versus -3.0 points (P = 0.0001).

The study also found that 50.7% of patients treated with pardoprunox experienced a greater than 30% reduction in UPDRS-Motor score, indicating a strong response rate, although side effects like nausea were reported in 47.1% of treated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease. Bronzova, J., Sampaio, C., Hauser, RA., et al.[2012]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06680830

NCT06680830 | A Phase 2 Study of NEU-411 in ... The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's ...

2. neuron23.com neuron23.com/neuron23-to-present-phase-1-healthy-volunteer-data-of-neu-411-a-brain-penetrant-lrrk2-inhibitor-at-ad-pd-2025/

Neuron23 to Present Phase 1 Healthy Volunteer Data ... NEU-411 is a brain-penetrant, potent and selective inhibitor of LRRK2 for the treatment of Parkinson's disease (PD). Initial findings will be ...

3. davisphinneyfoundation.org davisphinneyfoundation.org/blog/the-neulark-study/

The NEULARK Study and LRRK2-Driven Parkinson's Following a Phase I trial that involved more than 100 volunteers and found NEU-411 was shown to be safe and well tolerated, researchers for the ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/neuron23-neu-411/

Neuron23 doses first subject in Phase II trial of NEU-411 ... NEU-411 is designed to inhibit the overactive LRRK2 kinase pathway, addressing an underlying cause of the progression of the disease in people ...

5. ucihealth.org ucihealth.org/clinical-trials/ccr-24-67

A Phase 2, Randomized, Double-Blind, Placebo- ... The study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NEU-411, an orally-administered, potent, selective, ...

6. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-neu-411-for-patients-with-early-parkinsons-disease/

Study on the Safety and Effectiveness of NEU-411 for ... This clinical trial investigates the safety and effectiveness of NEU-411 for the treatment of early-stage Parkinson's disease driven by ...

7. mountsinai.org mountsinai.org/clinical-trials/phase-2-study-of-neu-411-in-companion-diagnostic-positive-participants-with-early-parkinsons-disease

A Phase 2 Study of NEU-411 in Companion Diagnostic ... Summary: The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early ...