Therapeutic area
Dementia with Lewy bodies
Developing digital measures and a real-world dataset to study movement, speech, cognition, and everyday function in dementia with Lewy bodies.
Dementia with Lewy bodies (DLB) is a progressive brain disorder associated with abnormal deposits of alpha-synuclein called Lewy bodies. Features can include changes in attention and alertness, visual hallucinations, disrupted sleep, and slow or stiff movements. Symptoms can fluctuate within a day as well as over time, making repeated assessment valuable for understanding everyday function and longer-term change.
$5.2M NIH support for digital biomarker research in PSP and DLB
Announced in September 2025, this five-year, $5.2 million NIH award supports the development and evaluation of digital biomarkers in progressive supranuclear palsy (PSP) and DLB. The project brings together BioSensics, academic investigators, and patient advocacy organizations.
Our research in DLB
Our DLB research has two connected aims: evaluating digital measures of movement, speech, cognition, and everyday function, and building a dataset that connects clinical assessments with daily-life recordings. The work is intended to support future studies of disease progression and evaluation of these measures for clinical trials.
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Digital measures
Digital measures for studying DLB symptoms
Combining wearable sensors and standardized digital tasks to study function at home and during clinical assessments.
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Real-world dataset
Building a real-world dataset for DLB
Baseline assessments and 14 days of home recording to study digital measures in DLB and mild cognitive impairment with Lewy bodies.
Digital measures for studying DLB symptoms
We combine wearable sensors with standardized speech, cognitive, and fine motor assessments. The research evaluates activity, posture, gait, and upper limb movement alongside clinical measures to understand their accuracy, reliability, and relevance to DLB. These tools are being studied as complementary measures of function between visits.
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PAMSys
A pendant sensor that measures walking, postural transitions, and time spent in different activities during daily life.
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PAMSys ULM
Wrist sensors that quantify upper limb movement and identify patterns consistent with goal-directed use during daily activity.
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PAMSys Gait
Ankle-worn sensors being evaluated for measuring walking patterns during daily life in the registered study.
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BioDigit Speech
Standardized speech tasks and automated analysis for studying speech characteristics and changes over time.
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Cognitive and fine motor assessments
Tablet-based tasks for repeated assessment of cognitive and fine motor performance at home.
Building a real-world dataset for DLB
The registered study pairs baseline clinical and digital assessments with 14 days of wearable recording at home. The dataset is intended to evaluate measurement accuracy and characterize everyday movement in DLB and MCI-LB, laying the groundwork for longer-term studies of disease progression.
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Complementary data sources
Wearable recordings of activity, posture, gait, and upper limb movement, paired with speech, cognitive, fine motor, and clinical assessments.
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Repeated measurement at home
Repeated wearable recordings at home can characterize day-to-day variation in movement beyond a single clinic visit. Speech, cognitive, and fine motor tasks are included in the baseline assessment.
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Toward longer-term monitoring
The initial study evaluates feasibility, reliability, and daily variability. These findings can inform the design of longer-term studies to test sensitivity to disease progression.
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Analytical and clinical validation
Comparisons with reference measurements will assess measurement accuracy. Associations with clinical assessments will help evaluate clinical relevance and inform future validation studies.
Our clinical study in DLB
The planned observational study includes people with DLB, MCI-LB, and PSP under one protocol. Baseline assessments are followed by 14 days of home recording. The June 2026 registry record lists the study as not yet recruiting, with a target of 30 participants with DLB or MCI-LB and 30 with PSP; the figure below is the combined total.
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Not yet recruiting
BioDigit DLB
- ClinicalTrials.gov
- NCT07240805 (opens in a new tab)
- Planned total enrollment
- 60
- At-home recording
- 14 days
Our research partners
Our DLB research brings together academic investigators and patient advocacy organizations.
- Johns Hopkins University
- Lewy Body Dementia Association
- Massachusetts General Hospital
- University of Hawaii
- University of Miami
Advance DLB research with digital measures
Explore digital measurement for DLB research. Discuss research collaborations, study protocols, and data access with our team.