Koneksa Achieves Key Milestone with Database Lock for KH007 Study Evaluating Parkinson’s Disease Progression

Completion of data collection enables full analysis, with topline results expected in June 2026

NEW YORK, NY, UNITED STATES, April 23, 2026 /EINPresswire.com/ -- Koneksa, a measurement-science partner for clinical development, today announced database lock for its KH007 study, a longitudinal observational study evaluating digital measures of Parkinson’s disease progression.

As adoption of digital measures in clinical research continues to expand, recent market analyses project sustained double-digit growth in digital biomarkers, driven by increasing demand for remote patient monitoring and more continuous, real-world data collection. At the same time, a key challenge remains: whether these measures can reliably detect clinically meaningful change in real-world and clinical settings.

Affecting more than 10 million people worldwide, Parkinson’s disease is characterized by progressive motor and non-motor symptoms that can significantly impact daily function and quality of life, underscoring the need for better therapies and measures of disease.

KH007 was designed to address this challenge through a measurement strategy aligned with clinically meaningful concepts of change. The Koneksa-sponsored study was conducted in a curated collaboration with partners Merck and Regeneron. KH007 leverages digital health technologies to capture both point-in-time assessments and continuous passive data enabling a more comprehensive and interpretable view of disease progression. The study enrolled 82 participants with 73 completing the one-year study, reflecting sustained participant engagement over time.

“As digital measures become more widely used, how those measurements are defined and applied will increasingly determine how confidently therapies can be evaluated in clinical development,” said David Lynch, Ph.D., Chief Executive Officer of Koneksa. “KH007 reflects this approach through the integration of multiple data streams to generate more reliable and interpretable evidence of disease progression.”

Interim analysis from the study demonstrated high patient compliance with remotely collected digital measures, with approximately 95% adherence to digital data capture. Results also showed strong test-retest reliability (ICC>0.75) across multiple measures. In addition, digital measures demonstrated criterion validity against established clinical scales, supporting their relevance in assessing motor function in Parkinson’s disease.

“This study represents years of collaboration across participants, clinical sites, and partners who made this work possible,” said Robert Ellis, Ph.D., Co-founder and Head of Biomarker Development at Koneksa. “We are incredibly grateful for their contributions. This work collectively lays the foundation for more sensitive and reliable measurement of neurological disease, therapies and, ultimately, better outcomes for patients.”

With database lock complete, Koneksa will proceed with full analysis of the dataset, with topline results expected in June 2026.

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.

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-science partner helping clinical development teams generate clearer and earlier decision-ready evidence. 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 quality reliability execution and integrated scientific interpretation, Koneksa supports more confident decisions throughout the clinical development lifecycle.

Learn more at koneksahealth.com.

Emma Primon
Koneksa Health
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