BlueRock to apply digital health technologies in observational study
Two-year study is enrolling up to 500 patients with at least three hours of off time
BlueRock Therapeutics will use digital health technologies from Rune Labs and Emerald Innovations to remotely monitor a subset of Parkinson’s disease patients in an observational clinical study.
The goal of the two-year study (NCT05363046) is to shed light on patients’ daily experiences with the neurodegenerative disease via patient diaries. It’s currently enrolling up to 500 Parkinson’s patients, ages 39-70, at sites in the U.S. and likely in Canada. Eligible patients must experience at least three hours of off time, when symptoms return between doses of standard levodopa-related treatment.
Rune and Emerald’s digital technologies will monitor the daily activities of 50 trial participants and measure key markers of disease progression.
BlueRock, a subsidiary of Bayer, hopes the results will inform the utility of remote digital data collection in future clinical trials of bemdaneprocel (BRT-DA01), its investigational cell-based therapy for Parkinson’s.
“Parkinson’s disease is incredibly complex, with symptoms often varying hour to hour through the course of the day,” Seth Ettenberg, president and CEO of BlueRock, said in a company press release. “We are excited to be working with the pioneering teams at Rune Labs and Emerald Innovations to harness the power of their digital health technologies to collect an unbiased, objective, and continuous measure of disease impact on function that will help us develop more effective therapies.”
Disease monitoring in Parkinson’s trials currently relies on intermittent clinical assessments of neurological function and mobility, along with subjective patient-reported outcomes from diaries and questionnaires. That approach, however, “fails to capture the dynamic nature of the disease,” Brian Pepin, Rune’s CEO, said in a separate press release.
When data aren’t collected in real time, the full picture of a person’s disease and its effects of daily life might be missed. New tools that could remotely collect symptom data constantly might better capture these changes, while easing the burden on patients to record their symptoms.
Study to create a ‘comprehensive image’ of Parkinson’s symptoms
Participants are being assigned to complete a Parkinson’s diary either three days in a row on one week or two days in a row on two consecutive weeks for each visit. Clinical visits will occur at regular intervals.
The trial’s sub-study of digital health technologies will be the first deployment of Rune’s StriveStudy clinical trial platform, which is designed to streamline trial enrollment and data collection, and monitor compliance to wearable devices.
It will also employ StrivePD, the company’s U.S.-cleared patient monitoring app. The system uses an Apple Watch and Apple’s Movement Disorders API software to record movement data and track common motor symptoms such as mobility problems, tremors, and dyskinesia (involuntary movements).
Emerald’s biosensor technology, which belongs to a class of sensors called invisibles, will collect data on patients’ walking speed, mobility, and sleep quality. The sensor uses artificial intelligence to collect health metrics from surrounding radio signals without the need for a wearable device.
The approach has “demonstrated strong correlation with the gold standards in Parkinson’s, while allowing clinical trials to reach robust evidence faster and with a smaller number of patients,” said Dina Katabi, PhD, co-founder of Emerald. “Our collaboration with BlueRock enables a data-driven clinical trial in Parkinson’s while patients go about their normal lives.”
Data collected with the two technologies, along with their feasibility, will be compared with standard assessments with the goal of determining their potential utility in future trials of bemdaneprocel.
The data will also help create a “comprehensive image of Parkinson’s symptoms,” Pepin said. “By establishing a baseline symptom dataset, we will be able to fully capture the benefits of novel advanced therapies, increasing the efficiency of clinical trials in the future.”
Bemdaneprocel is an experimental therapy that surgically delivers dopamine-producing neural progenitor cells into a patient’s putamen, the area of the brain that regulates movement. Dopamine is the major brain chemical messenger that’s progressively lost in Parkinson’s.
The therapy is expected to restore dopamine levels and slow or halt disease progression.
A Phase 1 trial (NCT04802733) is currently evaluating bemdaneprocel’s two-year safety, tolerability, and preliminary efficacy in 12 adults with advanced Parkinson’s disease who are having off periods or dyskinesia with levodopa. Results are expected in the second half of this year.
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