Parkinson’s Patient Advocate Sees Hope in Digital Biomarkers

Three years come to mind when patient advocate Cathy Molohan is discussing Parkinson's disease -- 1961, 2011, and 2020.

The year 1961 is when Levodopa was first shown to have a "miraculous" effect in patients with Parkinson's disease (PD). Today, more than 6 decades later, Levodopa remains the most potent medication for PD.

“I’m here to ask you a kind of impatient question from a patient perspective,” said Molohan, who was diagnosed with the disease in 2011. “What is taking so long?” She expressed her frustration during the AiCure webinar, Harnessing Technology to Unlock Meaningful Patient Insights.

Despite 357 Parkinson’s Disease trials testing 152 drug interventions from 1999 to 2019 there remains no approved disease-modifying treatments for PD.

The third landmark year for Molohan was 2020 when she completed surgery for deep brain stimulation. “It sounds kind of scary and it is kind of scary,” she said. After the procedure, Molohan decided to dedicate her life to patient advocacy. She saw it as her way to “influence R&D and policy making” and “not just hope someday that things will change.”

One of the ways Molohan has been pushing for change is by participating in clinical research. She has direct experience in a clinical study using AiCure’s platform for measuring treatment effects using digital biomarkers. AiCure’s Platform captures and analyzes behavioral variables, including head, upper extremity and hand motions, acoustics and vocal production, speech content and facial expressivity. It provides predictive analytics and interpretation using AiCure digital biomarker and medication adherence data.

Objectivity of digital biomarkers “better than trying to guess,” Molohan says

Before enrolling in the Parkinson’s Disease clinical trial, Molohan met every 6 months to monitor progress with her neurologist. She found these infrequent visits disheartening. “That feels terrible as a patient” to measure complex symptoms on a numerical scale, she said. “I was trying to guess or trying to remember how I felt 6 months ago. Could I walk up to a bar and carry two pints of Guinness down to the table at home in Dublin? No, I couldn't do that 6 months ago. I'd spill it everywhere.”

Better than relying on 6 months of memories about distinct symptoms was the “objectivity of using an app that can measure my tremor,” Molohan said during the AiCure webinar. “It measures tremor in my voice I don't even hear. It tells my physician how my facial expression has changed. It’s not like trying to guess or remember.”

Not content to just undergo major surgery in 2020, Molohan also brought her personal experience that year to the Yuvedo Foundation, where she serves as International Affairs Manager. The foundation's goal is to eliminate Parkinson's disease from the list of incurable diseases within a decade (by 2032).

Matthew Leoni MD MBA, VP, Global Clinical Development at Cerevel Therapeutics, shares Molohan's urgency for finding new Parkinson’s treatments. Both Molohan and Dr. Leoni are working to support a shift in trial methodology to rely on more patient-centric, sensitive measures of drug efficacy. Digital biomarkers, in particular, are a central part of this shift.

Limited progression endpoints in PD are commonly cited as reason for failure of trials, but digital biomarkers offer a valid, patient-first way to improve longitudinal tracking of impairments in clinical care and real-world research. Digital biomarkers are physiological traits of a disease that can be collected by remote technologies to assess disease progression, recruitment criteria and treatment response.

“Having worked with AiCure, they are probably the most advanced in facial recognition and mapping software and the algorithms underlying that to detect subtle clinical changes,” Dr. Leoni said during the AiCure webinar.

Of the platforms offering digital biomarker tools, AiCure uniquely captures a wider range of markers – from facial activity and body movement to speech content and acoustics. Dr. Leoni said most other development of biomarkers in Parkinson’s research focuses solely on actigraphy, movement or speech patterns as opposed to AiCure’s multimodal approach.

Combining digital biomarkers with traditional methods of subtyping provides a more comprehensive understanding of patient response and the disease. AiCure’s mission to expedite patient understanding at scale is maintained by its OpenDBM initiative, which is building transparent collaborations with industry and academia to bring further validation of digital biomarkers.

With over 20 digital biomarkers in its toolkit, AiCure improves understanding of patient behavior across several other therapeutic areas including Schizophrenia and PTSD.

“If there is any take home,” said Ed Ikeguchi MD, Chief Executive Officer at AiCure. “We understand the patient is so much more complex than we traditionally understood.”

Learn more by viewing the webinar, Harnessing Technology to Unlock Meaningful Patient Insights.