Early Successes in Remote Research: Enabling Enrollment in Clinical Trials

At Synapticure, we are proud to be part of Clene's Expanded Access Program (EAP) under the ACT for ALS initiative, which is making investigational therapies for ALS more accessible to patients across the United States. Our involvement in this program is already showing early successes, as we bring innovative care and clinical research opportunities directly to patients—regardless of their location or socioeconomic status.

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Breaking Barriers in ALS Care

Synapticure’s virtual platform is transforming access to clinical studies and treatment for people living with ALS. Traditional clinical trial models have often excluded patients due to geographic and financial constraints, with many having to travel hundreds of miles to participate. Synapticure's participation in the EAP eliminates these barriers by enabling remote enrollment and care. In fact, 44% of the patients currently engaged in the program live in neighborhoods ranked in the top third of the most socioeconomically disadvantaged areas in the country, based on ADI (Area Deprivation Index) national decile scores. The average distance these individuals live from the nearest NEALS-affiliated clinical site is 242 miles—yet they are receiving the same quality of care and research opportunities from the comfort of their own homes.

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Achieving High-Quality Data Collection and Care

One of the key aspects of this program is ensuring high-quality data collection and patient care. Synapticure has implemented a robust system of FDA-grade data collection and quality tracking across all 50 states. We’re seamlessly integrating in-home clinical outcome assessments, blood draws, and medication distribution following the same standards and protocols used in traditional, in-person sites. Blood samples from our patients are being stored alongside clinic-collected samples at BioSEND, allowing for long-term, comparative analysis.

Our commitment to high-quality data collection and patient care is not just a goal but a reality, with every step carefully validated to ensure consistency with in-clinic processes. This has enabled us to scale enrollment rapidly while maintaining excellence in research.

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Rapid Enrollment and Growing Impact

Despite initial expectations for slower enrollment, Synapticure’s innovative model has seen rapid growth. We are on track to enroll our entire allocation of approximately 80 patients (half the overall trial enrollment) within 5 months of launch. In the program's first two months, we prioritized establishing high standards for remote study coordination and quality sample collection and from patients nationwide. Our goal has always been to balance quality and speed, and now that our standard operating procedures (SOPs) are in place and quality benchmarks have been met, we are picking up enrollment at an accelerated pace. The early successes of this program not only highlight our ability to reach underserved populations but also demonstrate the scalability and feasibility of virtual care models in clinical research. This means future versions of this trial could enroll in three months or less, and, should quality standards hold, that for future research studies we can expand the population of patients who can participate and enroll to the tens of thousands of ALS patients who cannot access a NEALS site.

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Enhancing Future ALS Research and Care

Our work with Clene’s Expanded Access Program is paving the way for the future of ALS research and care. By creating a system that provides equitable access to investigational therapies, we are contributing to population-level insights that will benefit future studies and trials. The centralized nature of our data collection will provide researchers with valuable tools to develop more effective treatments for ALS and improve care for patients across the board. Our ability to rapidly enroll clinical studies and run FDA grade data collection beyond the four walls of the ALS centers of excellence provides opportunities to speed enrollment, enhance diversity and lower the cost of studies and trials. 

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Synapticure: Complementing Traditional Care Models

While traditional brick-and-mortar ALS clinics remain essential, Synapticure’s virtual care platform plays a critical role in expanding access to research and care. By working alongside these institutions, we complement their efforts by offering wraparound services, 24/7 support, and faster access to specialists. For patients unable to visit ALS Centers of Excellence, Synapticure provides a lifeline, ensuring they are not left out of crucial research opportunities and investigational therapies.

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Looking Ahead

Our participation in Clene’s Expanded Access Program is just the beginning. We remain committed to expanding access to high-quality care and research for people living with neurodegenerative diseases, no matter where they live or what challenges they face. Through continued collaboration with partners like Clene, we aim to push the boundaries of care and provide hope for patients and families affected by diseases like ALS, Parkinsons’s, Alzheimer’s and related dementias, and more.

Contact us at research-studies@synapticure.com.

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