Objective: To determine the feasibility of using in-home digital biomarkers (DBs) and activity monitoring for clinical trials and studies of early Parkinson’s Disease (PD) and establish the DBs correlation to medication taking and real-world clinical change over time.

Background: Integrating ambiently captured DBs simultaneously referencing multiple domains of function (mobility, cognition, sleep, social interaction, medication taking, etc.) provides continuous, objective, real-world data. This data can reduce sample sizes needed to show efficacy or potential harm in clinical trials. Here we report on the methodology, and baseline and initial results of the intensely monitored EVALUATE-PD cohort of PD patients and their study partners.

Method: Participants were adults with idiopathic PD diagnosed within 3 years of study recruitment or with clinically early-stage PD, a study partner who lives in home or spends ≧3 hours/week with the person with PD, and is using a PC, laptop, tablet or smartphone. Baseline standard clinical measures (vital signs, UPDRS, Patient Reported Outcomes in PD, cognitive battery, behavioral scales, etc.) are obtained along with DBs captured with primarily passive in-home sensors (actigraphy, bed mats, infra-red activity sensing, e-pillbox, computing device use, in-vehicle driving sensors, regular online reporting/cognitive assessment).  Presented in this report are feasibility of recruitment, enrollment, and retention, and initial summary statistics of adherence and clinical and DB metrics.

Results: Study flow is given in a CONSORT diagram [Figure 1]. Forty-eight PD patients and partners have been enrolled with no dropout over a mean(SD) follow-up of 35.9(12.2) weeks. Summary statistics of adherence and clinical and DBs are in [Table 1]. An example of time aligned multi-domain DB data is shown in [Figure 2].

Conclusion: High adherence and home-based continuous data capture of multi-domain DBs is feasible in early PD patients and their partners.  This suggests that multiple DBs which can be more sensitive as meaningful indicators of clinically relevant changes are capable of being incorporated into clinical studies of early PD patients. Longitudinal follow-up will further substantiate the sustainability and sensitivity to change over time of this approach.

Figure 1. EVALUATE-PD CONSORT Study Flow Diagram

Figure 2. DB and Experience Sampled Data Example

Table 1. Participant Characteristics

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MDS Abstracts - https://www.mdsabstracts.org/abstract/ecologically-valid-ambient-longitudinal-and-unbiased-assessment-of-treatment-efficacy-in-parkinsons-disease-evaluate-pd/