Splash Clinical and C2N Diagnostics announced today a groundbreaking partnership aimed at transforming recruitment efficiency for Alzheimer's disease clinical trials throughout the United States and globally. The collaboration combines Splash Clinical's proprietary recruitment infrastructure with C2N's innovative PrecivityAD2™ blood tests to create a comprehensive pre-screening approach that could significantly reduce the high screen failure rates currently plaguing Alzheimer's research.
The partnership addresses a critical bottleneck in Alzheimer's drug development, where screen failure rates often exceed 70% according to Goldman et al. (2020), substantially delaying trial timelines and increasing costs for sponsors. By implementing more accurate pre-screening methods, the companies aim to accelerate the development of potential treatments for the estimated 6.7 million Americans currently living with Alzheimer's disease.
Advanced Blood Testing for Amyloid Detection
C2N's PrecivityAD2 is a high-accuracy blood test designed for patients 55 and older exhibiting signs of mild cognitive impairment or dementia. The test aids in detecting amyloid plaques in the brain—a pathological hallmark of Alzheimer's disease—with diagnostic performance comparable to more invasive and expensive methods like amyloid PET scans and cerebrospinal fluid (CSF) biomarker analysis.
"Our partnership with C2N Diagnostics is a step forward in our mission to transform clinical trial enrollment," said Matt Teuteberg, CEO of Splash Clinical. "We believe by using C2N's PrecivityAD2 blood tests in our platform, we can reduce screen failure rates while saving valuable time and resources for our partners. In the end, this means getting potentially life-changing treatments to patients faster."
Streamlined Patient Journey Through Concierge Service
A key component of the partnership is a specialized patient concierge service that will guide participants through the pre-screening process and coordinate PrecivityAD2 testing and trial participation. This service aims to ensure a smooth experience for both patients and clinical sites while reducing time and resource demands.
By developing this integrated solution, Splash Clinical aims to lower recruitment costs and timelines, maintain high-quality standards, and enable researchers to access a broader, more diverse population while ensuring participants meet trial criteria before site visits.
Dr. Joel Braunstein, C2N CEO, emphasized the importance of the collaboration: "C2N Diagnostics prides itself on collaborating with the leading entities and researchers in the world to better understand the causes of Alzheimer's disease as well as ways to better diagnose and treat it. This is why we're excited to partner with Splash and its patient-centric platform focus."
Proven Expertise in Neurological Research
The collaboration builds on both companies' established expertise. C2N's assays have been used in over 150 Alzheimer's disease and other research studies worldwide, including landmark treatment and prevention trials involving disease-modifying therapies. The company has reported over 50,000 Precivity™-related biomarker measures through peer-reviewed publications.
Splash Clinical brings its track record of successful partnerships in the Central Nervous System (CNS) space, offering sponsors and research organizations tools to improve enrollment in clinical trials while enhancing healthcare equity among study participants.
Addressing the Alzheimer's Clinical Trial Challenge
The Alzheimer's clinical trial landscape has historically faced significant challenges in patient recruitment and retention. Traditional screening methods often require multiple visits and invasive procedures, creating barriers to participation, particularly among underrepresented populations.
By implementing blood-based biomarker testing earlier in the screening process, the partnership aims to identify appropriate candidates more efficiently, reducing the burden on both patients and clinical sites. This approach could potentially expand access to clinical trials for diverse populations who have traditionally been underrepresented in Alzheimer's research.
Global Reach and Impact
The partnership's scope extends beyond the United States, with potential global implications for Alzheimer's research. C2N has already established partnerships with leading clinical diagnostic labs worldwide, including Unilabs across Europe, Grupo Fleury in Brazil, Healius Pathology in Australia, and Mediford Corporation in Japan.
This extensive network, combined with Splash Clinical's digital solutions for trial enrollment, positions the partnership to address recruitment challenges on a global scale, potentially accelerating the development of new treatments for the estimated 55 million people living with dementia worldwide.
As clinical trials for disease-modifying Alzheimer's treatments continue to advance, efficient recruitment strategies will be crucial for bringing potential therapies to patients more quickly. The Splash Clinical and C2N Diagnostics partnership represents a significant step toward overcoming one of the most persistent challenges in Alzheimer's drug development.
