In a significant advancement for Parkinson’s disease research, Annovis Bio has partnered with NeuroRPM to integrate an FDA-cleared, AI-powered wearable platform into its long-term open-label extension study of buntanetap. The technology will provide continuous, real-time monitoring of key motor symptoms—bradykinesia, tremor, and dyskinesia—serving as objective digital biomarkers to track symptom changes and treatment effects over the 36-month trial period. This collaboration enhances data granularity in a study enrolling up to 500 participants across U.S. sites, building on prior evidence of buntanetap’s potential to improve cognition and halt decline in Parkinson’s patients.
Advancing Precision Monitoring in Parkinson’s Research
Annovis Bio has entered into a strategic partnership with NeuroRPM to incorporate cutting-edge digital health technology into its ongoing open-label extension (OLE) study for Parkinson’s disease (PD). The study, identified as ANVS-25002 (NCT07284784), launched enrollment in early 2026 and focuses on evaluating the long-term safety and tolerability of buntanetap, an investigational oral therapy designed to address underlying neurodegenerative processes.
Buntanetap works by inhibiting the production of multiple neurotoxic proteins, including amyloid-beta, tau, alpha-synuclein, and TDP43, which accumulate in Parkinson’s and contribute to motor and cognitive impairments. Previous Phase 3 data in early PD demonstrated that buntanetap halted cognitive decline across the study population, with particularly robust improvements—up to three times greater—in patients showing Alzheimer’s-like amyloid co-pathology, affecting about 25% of participants. Biomarker analyses further supported disease-modifying effects, including reductions in plasma TDP43 by over 70% in earlier trials.
The OLE study targets up to 500 participants aged 40-85 with Hoehn and Yahr stages 1-3, including two cohorts: those who previously participated in buntanetap trials and individuals at least 12 months post-deep brain stimulation with stable settings. Participants receive once-daily 30mg buntanetap for 36 months, with assessments including clinical measures, skin and plasma biomarkers, and now enhanced digital monitoring.
NeuroRPM’s platform, cleared by the FDA via 510(k), utilizes the Apple Watch to capture motion data continuously during daily activities. Advanced AI algorithms analyze this data in real time to detect and quantify three cardinal PD motor symptoms: bradykinesia (slowness of movement), tremor (involuntary shaking), and dyskinesia (uncontrolled movements often linked to levodopa therapy). The system integrates supplemental health metrics from Apple HealthKit, delivering objective, granular insights that traditional in-clinic assessments—typically episodic and subjective—cannot match.
This deployment addresses a critical need in PD trials: capturing real-world symptom fluctuations and treatment responses with high precision. By providing continuous data streams, the technology offers digital biomarkers that can reveal subtle changes over time, potentially correlating motor improvements with buntanetap’s mechanism of action. Benefits include:
Real-time AI detection of symptom severity and patterns
Improved patient accessibility through mobile integration and remote monitoring
Enhanced trial data quality with objective metrics complementing clinical scales like MDS-UPDRS
Better understanding of symptom variability in everyday environments
The partnership aligns with broader trends in neurodegenerative research, where wearables and AI are transforming endpoint measurement. Continuous monitoring reduces reliance on infrequent clinic visits, minimizes patient burden, and provides richer datasets for analyzing disease progression and therapeutic impact.
In the context of Annovis Bio’s broader pipeline, this initiative supports ongoing efforts in PD and Alzheimer’s disease. The company maintains a pivotal Phase 3 trial in early Alzheimer’s, with recent Data and Safety Monitoring Board approvals confirming buntanetap’s safety profile at interim points, showing consistency across indications. Discussions with regulators continue for potential future studies in PD dementia, informed by prior cognitive benefits observed.
By embedding NeuroRPM’s technology, the OLE study positions itself at the forefront of digital innovation in clinical research. Objective digital biomarkers could strengthen evidence of buntanetap’s sustained effects, offering clearer signals on long-term efficacy beyond traditional outcomes. As enrollment progresses across 25 U.S. sites, this collaboration underscores a commitment to more comprehensive, patient-centered trial designs in the pursuit of effective treatments for Parkinson’s disease.
Disclaimer: This article is for informational purposes only and does not constitute investment advice, medical advice, or recommendations. All information is based on publicly available data as of the latest updates.
