Insights from the Ametris Digital Data Summit (ADDS) 2026 Pre-Conference Workshop
At the annual ADDS 2026 conference in Atlanta earlier this year, Ametris held a pre-conference workshop on Huntington’s Disease (HD), bringing together a diverse group of stakeholders including clinical experts, regulators, digital health technology (DHT) developers, and academic researchers. The session served as a timely forum to reflect on the current state of HD clinical development and explore how DHTs can reshape the future of outcome measurement and HD clinical trials.
Huntington’s disease presents a uniquely complex challenge for clinical trials. As a progressive, autosomal dominant neurodegenerative disorder, it affects both motor and non-motor domains in ways that are often subtle during early stages. While traditional clinical outcome assessments such as the Unified Huntington’s Disease Rating Scale (UHDRS) have long served as the standard, workshop discussions highlighted several critical limitations in the current clinical development landscape, including disease heterogeneity and challenges with patient stratification, subjectivity and susceptibility to placebo effects in clinician-rated measures, limited sensitivity to early-stage changes, lack of alignment on key concepts of interest and their clinical meaningfulness, and insufficient capture of real-world patient experience alongside usability considerations for digital health technologies.
A consistent theme emerged that existing tools are not adequately equipped to detect the nuanced, real-world manifestations of HD, particularly as the field increasingly shifts toward earlier intervention.
During the roundtable discussion on the future of outcome measures in Huntington’s disease (HD), participants highlighted key gaps in current approaches and articulated a vision for more robust and meaningful assessments. Existing measures were criticized for being largely subjective, episodic, and insufficiently sensitive to detect early disease changes, with limited patient-centricity and inadequate capture of important domains such as sleep and cognition. In contrast, the ideal future state emphasizes the adoption of objective and continuous measurement approaches with high sensitivity to early progression, alignment with HD-ISS frameworks, and the development of patient-centric, clinically meaningful endpoints. Collectively, these advances aim to enable greater precision and a more holistic characterization of disease burden and progression in HD.
Key Opportunities for Digital Measurement in HD were presented with data. Gait metrics emerged as one of the most promising digital biomarkers. Data showed the DHTs were able to demonstrate increased step-to-step variability and irregularity, reduced gait velocity in pre-manifest HD, and detectable abnormalities even with low chorea.
Interestingly, it was shown that while overall activity levels may remain unchanged, movement quality deteriorates, making gait variability a sensitive marker of progression. Novel wearable-derived measures, such as truncal chorea demonstrated sensitivity to treatment effects in studies like CONNECT-HD. DHTs were able to differentiate between prodromal and manifest HD through activity patterns and sleep disturbances (e.g., increased nocturnal movement).
Overall, potential measures of interest that can offer valuable insights into functional decline in HD included step regularity, variability, and irregular movements in gait, chorea (upper extremity), sedentary time and total daily physical activity, time in bed, and sleep fragmentation.
Physiological measures, including heart rate variability and respiration during sleep, may further inform disease progression and overall health status.
Gait, chorea, movement (pronation/supination, flexion/extension, finger tapping) and sleep were identified as key concepts. The open discussion touched various topics around these concepts in terms of evidence generation, patient meaningfulness, potential regulatory pathways and endpoint positioning. A problem of “plenty” in terms of digital measures was discussed and the need for consolidation and validation was highlighted.
Despite the richness of digital data, a critical question remains: which metrics truly matter to patients? For example, while step irregularity may be highly sensitive, its clinical and patient relevance must be established. Workshop discussions emphasized that not all meaningful endpoints originate from patient-reported experiences. It was also discussed that the longitudinal datasets, which are currently lacking in HD, are key to linking digital signals with clinical outcomes and data-driven approaches are essential for identifying sensitive markers. To address this critical need, several approaches such as central-IRB driven, externally funded data collection efforts were discussed.
The workshop underscored a pivotal shift in HD clinical development: while traditional outcome measures remain insufficient to capture early, subtle, and real-world disease manifestations, DHTs offer a transformative path forward through objective, continuous, and patient-centric measurement. Realizing this potential, however, requires first defining clinically meaningful questions, aligning endpoints with frameworks such as the HD-ISS, strengthening collaboration between sponsors and technology developers for evidence generation and regulatory readiness. Emerging evidence highlights gait, movement, sleep, and physiological signals as promising concepts of interest, yet translating these data into regulatory-grade, patient-relevant endpoints remains a key challenge—one that depends on robust longitudinal datasets, thoughtful endpoint selection, and strategies to ensure adherence and data quality. While these challenges remain, growing evidence, cross-sector collaborations, and increasing patient willingness to engage with these technologies signal strong momentum. Collectively, these advances position the field to move toward more precise, efficient, and impactful clinical trials—bringing the promise of earlier intervention and better outcomes for individuals with HD closer to reality.
To learn more about Ametris DHT solutions for Huntington's Disease research, contact us and set up a meeting with a member of our team!
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