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March 21, 2022

AD/PD 2022: digital health tools are a winner in prasinezumab clinical trials

Much of the positive data on the effect of prasinezumab on motor signs in PD was captured using a novel digital health technology.

By GlobalData Healthcare

At the AD/PD 2022 International Conference on Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), Roche presented new data from its prasinezumab clinical programme during a 19 March session on advances in PD and lewy body dementia (LBD) drug development. As part of the session, new data was presented on part two of the drug’s Phase II PASADENA study (NCT03100149). Much of the positive data on the effect of prasinezumab on motor signs in PD was captured using a novel digital health technology developed by Roche. 

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Prasinezumab is a monoclonal antibody targeting alpha-synuclein, the aggregation of which is a major component of PD pathology. In part one of the PASADENA study (Weeks 0–52), patients were randomised to receive either prasinezumab or placebo, while in part two (Weeks 52–104), patients either continued on prasinezumab or switched from placebo to receive treatment. The first part of the PASADENA study failed to meet its primary endpoint, the change from baseline in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) total score. But when looking at the score’s motor examination subsection, MDS-UPDRS Part III in isolation, prasinezumab treatment resulted in a significantly reduced clinical decline in motor signs at week 52 compared with placebo.

One important aspect of PD pathophysiology is the fluctuating symptoms experienced by patients. Because of this, it can be difficult for investigators to capture the effect of an investigational drug through traditional methods of assessment during infrequent clinic visits. In contrast, the use of digital health technology allows for continuous, remote monitoring of patients, potentially enabling more accurate analysis of treatment effects. The digital health technology developed by Roche uses a smartwatch to passively measure aspects of motor function such as mobility and gait, as well as a mobile application that actively measures motor function through targeted tests including those for dexterity, tremor, balance, and U-turn (speed of turning while walking). Despite the continuous, daily nature of this remote testing, results showed that adherence remained strong throughout the two-year duration of the trial, with the mean number of days per week patients participated in the active testing dropping only slightly from 5.73 days a week in part one to 5.01 days a week in part two.

Previously presented data from part one of the trial demonstrated that prasinezumab treatment was associated with decreased progression of upper limb bradykinesia, as measured by a speed tapping test on the mobile application and hand gesture power via the smartwatch. New data from part two of the study suggested the positive effects seen in part one had persisted. Additionally, new data from part two showed the positive effect of prasinezumab in an additional measure not seen in part one, the U-turn test, highlighting a long-term treatment benefit of prasinezumab.

Prasinezumab has advanced into a Phase IIb study (PADOVA; NCT04777331) to further evaluate and confirm its efficacy in preventing clinical decline in motor signs among patients with early-stage PD. This study will continue to use Roche’s digital health technology as an important tool to assist in evaluating the clinical effect of prasinezumab. Roche announced that further qualitative and quantitative data will be presented later this year focusing on the patient and caregiver experience surrounding the daily use of digital health technology. These results could provide important insights on any potential burden of using digital health technology in clinical trials, which could influence whether its use will become more widespread in future PD trials.  

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