At the AD/PD 2024 International Conference on Alzheimer’s and Parkinson’s Diseases, Roche presented new data from its Phase II PASADENA trial, which evaluated the efficacy of intravenous prasinezumab in patients with early Parkinson’s disease (NCT03100149). The presentation explored the effect of prasinezumab on digital speech tests and the utility of acoustic measures as a biomarker for dysarthria progression in Parkinson’s patients.
A challenge in Parkinson’s is the difficulty with assessing disease progression and capturing the improvement of symptoms in patients using current methods, which are limited to clinical examinations. Unfortunately, the underlying pathophysiology of Parkinson’s is not fully understood. As a result, there are no pathological or imaging-based biomarkers to measure a patient’s progression other than clinical examination and monitoring the history of symptoms. Pivotal clinical trials for Parkinson’s typically require hundreds of patients, and assessments are limited to observational methods and patient self-assessments. Furthermore, due to the fluctuating symptoms experienced by patients with Parkinson’s, it can be difficult for investigators to capture the effect of an investigational drug through traditional methods of assessment during infrequent clinic visits, where physicians take only a single snapshot of what may be a series of motor fluctuations with varying severity. As such, there has been an increase in digital health technology tools (DHTTs) to enable remote patient monitoring of participants in clinical trials. According to GlobalData’s Clinical Trials Database, there are 14 ongoing Phase II–III trials in Parkinson’s that utilize wearable devices or mobile technology including mobile applications and smart devices.
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At AD/PD 2024, Roche presented digital speech data collected from the Roche PD Mobile Application v2, which is a DHTT installed on the patient’s smartphone to measure both the motor and non-motor symptoms of patients with early-stage Parkinson’s (Hoehn and Yahr I–II). The application actively measured motor function through targeted tests including those for dexterity, tremor, balance, and U-turn (speed of turning while walking). In addition, the application administered a speech test every second day, where the patient was instructed to read and answer the question out loud. The reading and spontaneous speech samples were used for analysis of hypokinetic dysarthria, a characteristic of early Parkinson’s, where the speech profile of patients has progressive deficits including increased speech monotonicity and reduction in volume, articulatory precision, and clarity. The 18 acoustic measures of hypokinetic dysarthria, including speech duration, volume, prosody, voice quality, and articulation, were included in the analysis. The study found that five out of the 18 acoustic measures had slower disease progression in the prasinezumab group compared to placebo control, including voicing variability, upper harmonicity range, intensity variability, spectral shape modulation, and speech duration. As such, prasinezumab may ameliorate the progression of hypokinetic dysarthria as measured with digital acoustic markers in the exploratory analysis.
The expanding use of DHTTs to monitor Parkinson’s symptoms continuously and remotely is expected to help bolster the density of outcome data in Parkinson’s clinical trials. A digital measure of disease progression can potentially enable a more accurate analysis of treatment effects. Roche’s PD Mobile Application v2 demonstrates the promise of remotely collecting speech samples to track the progression of speech and dysarthria progression in Parkinson’s clinical trials, though further research is needed to better understand and elaborate on the findings from this study. This includes additional research required to establish a link between patient-reported speech symptoms during daily activities and digital measures of speech impairment through the application’s speech tests, as well as to evaluate the sensitivity of digital speech measures in different Parkinson’s patient populations, including early-stage patients at the prodromal phase of the disease and those on stable symptomatic treatment. With the increasing number of disease-modifying treatments in development for Parkinson’s, DHTTs should be adopted in clinical trials to enable frequent remote patient monitoring and assessment of Parkinson’s disease progression.
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Roche Diagnostics International Ltd