Study meets primary compliance endpoint, reinforcing the value of Koneksa’s integrated measurement platform and syndicated, precompetitive study model with partners Merck and Regeneron.
Punta Gorda, FL — September 1, 2026 —Koneksa Health (Koneksa), a measurement and data science partner for clinical development, today announced positive topline results from its KH007 study (NCT06219629), a 12-month observational study evaluating digital measures of Parkinson’s disease (PD) progression.
The study met the primary endpoint, with a 95% CI for mean participant compliance of 80–88%, exceeding the predefined 75% threshold on the lower CI bound. Participants achieved this while completing a demanding assessment battery, 11 motor tasks, four speech tasks, and the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) electronic patient-reported outcome (ePRO), across the 12-month study, amid individualized schedules, protocol amendments, and medication changes.
Affecting more than 10 million people worldwide, PD is characterized by progressive motor and non-motor symptoms that can significantly impact daily function and quality of life. As digital measures gain adoption in clinical research, sponsors have long asked whether participants can sustain engagement with a comprehensive, multi-modal protocol over an extended period, not just a brief validation window. KH007’s topline results demonstrate that participants can achieve this level of engagement across a demanding, multi-modal 12-month protocol.
Conducted in a curated collaboration with partners Merck and Regeneron, the study enrolled 82 participants with PD (out of 100 screened), with 73 completing the full one-year study. Rather than validating a single device or algorithm, KH007 evaluated an integrated measurement platform spanning a mobile application, wearables, passive sensors, active motor and speech assessments, and ePRO, combining point-in-time task-based data with continuous passive monitoring to capture a more comprehensive and interpretable view of disease progression.
“KH007 reflects why we built our data syndication model and chose to sponsor a study of this scope ourselves,” said David Lynch, Ph.D., Chief Executive Officer of Koneksa. “Asking partners to co-invest in a shared, precompetitive dataset requires more than a compelling thesis. It requires evidence that the underlying measurement platform withstands the demands of a real, extended clinical study. KH007 provides that evidence, for us and for our partners, and it reinforces our conviction that this model has a meaningful role to play in how digital biomarkers are validated and adopted across drug development.”
“In clinic, I may see a patient for a thirty minutes every several months, a snapshot that misses much of what happens in between, “said Daniel Claassen, MD, MS, Chief Executive Officer of the Huntington Study Group and Professor of Neurology at Vanderbilt University Medical Center. “That limitation is not specific to Parkinson’s disease. Across neurodegenerative diseases, we are asked to detect gradual, fluctuating change through brief, episodic visits. What makes KH007 impressive is the demonstration that patients are willing to carry the burden of continuous measurement when it is asked of them. For those of us designing trials in Huntington’s and related conditions, it suggests that the limiting factor has been our ability to quantify changes over time, not our patients.”
Koneksa is now finalizing the study’s other analyses, including validity, reliability, and responsiveness to change, of the digital measures collected, and looks forward to sharing those results as they become available.
About KH007
KH007 Disease Progression Study is a 12-month observational study conducted in a curated collaboration with pharmaceutical partners, Merck and Regeneron, enrolling 82 participants with Parkinson’s disease (out of 100 screened). The study is designed to evaluate the reliability, validity, and longitudinal sensitivity of digital measures derived from digital health technologies (DHTs), including at-home active assessments, passive wearable monitoring, and in-clinical evaluations.
These measures enable both point-in-time task-based assessments and continuous passive monitoring, integrating multiple data streams, including motor assessments, speech, actigraphy, cognitive tasks, and patient-reported outcomes (PROs), to support more sensitive signal detection and a more continuous and interpretable view of disease progression. The study incorporates periodic in-clinic visits followed by remote data collection, including continuous passive monitoring and structured at-home assessments, to capture changes in motor and non-motor symptoms over time. Assessment frequency varied over the course of the study: through the first 90 days, participants completed select assessments daily or weekly, then shifted to a structured, periodic data-collection cadence for the remainder of the 12-month study, a design intended to mirror the assessment burden of longer Phase 2 and Phase 3 trials.
The DHT measures were selected based on literature review and partner input on concepts of relevance that are amenable to remote digital data collection and safe for participants to perform at home. The Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) remains a clinical standard; however, given its potentially limited sensitivity to detect subtle changes early in disease progression, DHT-derived measures are anticipated to enable more sensitive measurement of early disease in clinical and real-world settings.
About Koneksa Health
Koneksa is a measurement and data science partner helping clinical development teams generate clearer, earlier, and more decision-ready evidence. The company’s portfolio spans intelligent software, measurement science, and data services, including endpoint strategy, digital biomarker development, biometrics, statistical programming, and regulatory submission support. By designing measurement strategies grounded in disease biology and therapeutic intent, Koneksa integrates physiological, clinical, and digital signals to reduce variability and clarify treatment effects. Through high-reliability execution and integrated scientific interpretation, Koneksa supports more informed decision-making throughout the clinical development lifecycle.
Learn more at koneksahealth.com.
