New PD Trial Navigator program flags thousands for NEULARK study

More than 2,000 potential participants have been identified for screening in a Parkinson’s clinical trial, thanks to the Parkinson’s Foundation‘s PD Trial Navigator matching program. The Phase 2 trial (NCT06680830), known as NEULARK, is evaluating Neuron23‘s experimental therapy, NEU-411, in up to 150 people with early-stage, LRRK2-driven Parkinson’s disease. Patient recruitment is currently underway across 70 sites in the U.S. and Europe.

The PD Trial Navigator was launched in 2025 to help match people with Parkinson’s to gene-targeted clinical trials, a key goal of the PD GENEration program. The international research initiative has provided free genetic testing and counseling to more than 30,000 individuals with Parkinson’s from 10 countries since its launch in 2019.

“The initial success with genetically identifying individuals for the NEULARK trial is encouraging, as the combined power of the PD GENEration database and Neuron23’s precision tools, has already significantly streamlined the prescreening process for this investigational treatment,” James Beck, PhD, Parkinson’s Foundation’s executive vice president and chief scientific officer, said in a press release.

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“We believe the future of Parkinson’s treatment lies in understanding the biology driving each person’s disease and connecting the right individual to the right therapies earlier,” added Arash Rassoulpour, PhD, Neuron23’s chief operating officer. “Efforts like this are essential to advancing a new generation of targeted therapies aimed at slowing the progression of Parkinson’s disease.”

Results from the PD GENEration studies (NCT04057794 and NCT04994015), involving 29,500 participants who completed genetic testing, showed that 12.1% carried a Parkinson’s disease-associated genetic variant. These findings were recently reported in the preprint article “PD GENEration: An International Parkinson’s Disease Genetic Research Study.”

In addition, a 2024 survey of nearly 4,000 PD GENEration participants found strong interest in research participation: 85% indicated they would like to be contacted about future clinical trials, and 64% expressed willingness to enroll in trials offering telehealth participation.

Mutations in the LRRK2 gene are a common genetic cause of Parkinson’s disease. These mutations increase the activity of the LRRK2 enzyme, which can disrupt lysosomal function — the cellular recycling system that breaks down and clears damaged or unwanted molecules. Impaired lysosomal activity may promote the accumulation of toxic protein aggregates, contributing to inflammation, neuronal dysfunction, and ultimately the degeneration of nerve cells.

Although LRRK2 mutations account for about 2% of Parkinson’s cases, 30% of those without such mutations may still have an overactive LRRK2. Neuron23 has identified various single-nucleotide polymorphisms (SNPs) — small genetic variations in the LRRK2 gene — that may contribute to the enzyme’s overactivity.

Following favorable safety and tolerability results in a Phase 1 study (NCT05755191) in healthy adults, NEU-411 advanced into the NEULARK Phase 2 trial for Parkinson’s patients with LRRK2 mutations. The PD Trial Navigator program played a key role in recruitment by identifying genetically eligible participants, demonstrating the program’s scalability and potential to expand patient access and accelerate trial recruitment.

“Through our collaboration with the Parkinson’s Foundation and PD GENEration, we’re helping identify individuals whose Parkinson’s may be driven by LRRK2 biology and creating a pathway for them to participate in precision medicine research,” Rassoulpour said.

Participants in the NEULARK trial will be randomly assigned to receive NEU-411 or a placebo once daily for one year. Dosing started last year.

The trial’s main goals are to assess the treatment’s safety and its effects on Parkinson’s symptoms, using the Roche Parkinson’s Disease application, a smartphone-based digital tool to track movement, tremor, cognition, and other symptoms in real time. Secondary outcomes include standard neurological evaluations using the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale.