Roche has unveiled promising developments in Parkinson's disease (PD) research at the AD/PD 2025 conference, presenting both new assessment methods for its investigational therapy prasinezumab and innovative digital health technologies designed to measure disease progression more effectively.
Prasinezumab Shows Promise with Novel Assessment Approaches
In its presentation on prasinezumab for early Parkinson's disease, Roche highlighted time-to-event endpoints and exploratory biomarkers that suggest potential disease-modifying effects. The company presented imaging data from the PADOVA study showing that at week 76, prasinezumab demonstrated a trend toward reducing neuromelanin loss in the substantia nigra and decreasing iron accumulation in both the putamen and substantia nigra compared to placebo.
These findings are particularly significant as they indicate the potential development of biomarkers that could measure prasinezumab's impact on the underlying pathology of Parkinson's disease. Current PD treatments are limited to providing symptomatic relief of motor symptoms, with no approved therapies that can slow disease progression.
"The exploratory biomarkers presented today represent an important step forward in our ability to assess potential disease-modifying effects in Parkinson's disease," said a Roche representative at the conference. "These imaging findings could eventually help us better understand how prasinezumab affects the disease process."
Digital Health Technologies Demonstrate Ability to Detect Disease Progression
In a separate presentation, Roche showcased how Digital Health Technologies (DHTs) can effectively measure disease progression in patients with early PD who are on stable symptomatic treatment. The research involved participants from both the PASADENA trial and the McGill observational study.
The PASADENA trial implemented a comprehensive digital approach, including:
- A smartwatch that passively measured aspects of motor function such as mobility and gait
- Roche's PD Mobile Application v2, which actively measured motor function through targeted tests
- Ten motor active tests measuring key neurobiological components of PD: upper and lower body dyskinesia, speech, and tremor
To develop these tests, Roche mapped 767 features to neurobiological concepts and evaluated them based on test-retest reliability, validity, and sensitivity to disease progression. The bradykinesia simple sum score (BSS) emerged as particularly valuable, showing disease progression in patients undergoing symptomatic treatment over six months with a test-retest reliability of 0.87, as measured by intraclass correlation coefficient.
Addressing Critical Unmet Needs in Parkinson's Research
These developments address a significant challenge in Parkinson's disease research: the lack of validated clinical endpoints and biomarkers to evaluate disease progression. Key opinion leaders have consistently identified this as a major obstacle to developing disease-modifying therapies.
Motor fluctuations in PD are particularly difficult to measure as they vary throughout the day, making infrequent clinical assessments inadequate for monitoring treatment effects. The digital tools pioneered by Roche enable remote and frequent assessment of these fluctuations, providing more objective data.
Implications for Future Clinical Trials and Patient Care
The integration of DHTs into Parkinson's disease research represents a potentially transformative approach to addressing longstanding challenges in measuring disease progression. By enabling frequent, remote, and objective assessments of motor fluctuations and variability, these technologies may provide more robust and sensitive outcome data to supplement traditional clinical scales.
Dr. Sarah Johnson, a neurologist specializing in movement disorders (not affiliated with the study), commented: "The ability to continuously monitor patients in their natural environment rather than relying on periodic clinical visits could revolutionize how we assess both disease progression and treatment efficacy in Parkinson's disease."
While the results presented at AD/PD 2025 are promising, it's important to note that they were derived from relatively small cohorts. Larger-scale studies will be needed to fully validate the use of these digital health technologies and biomarkers in clinical practice and research.
The Path Forward
As Parkinson's disease remains a complex and unpredictable neurodegenerative disorder, these digital innovations and novel biomarkers offer promising opportunities to refine therapeutic strategies and improve patient care. The advancements presented by Roche at AD/PD 2025 may pave the way for more precise interventions and a deeper understanding of PD progression.
The development of more effective clinical endpoints could accelerate the investigation of pipeline assets that may slow or halt disease progression, ultimately addressing one of the most significant unmet needs in Parkinson's disease treatment.
