8:00 am Morning Refreshments
8:25 am Chair’s Opening Remarks
MAKING IT A REALITY: SHOWCASING DIGITAL MEASURES FOR INTERVENTION ACROSS NEURODEGENERATION
8:30 am Advancing a Medical Device Technology to Slow Cognitive Decline and Modify Disease Progression in Alzheimer’s Disease
Synopsis
- Leveraging an innovative medical device technology to target participantfunction, cognition, and brain structure in Alzheimer’s Disease
- Launching our pivotal HOPE study in participants with mild-moderateAlzheimer’s Disease to demonstrate safety and efficacy
9:00 am The Need for Novel Endpoints: A Case for Using Multimedia, Audio & Video to Capture Novel Digital Endpoints
Synopsis
- Outlining the need for novel digital endpoints in neurological clinical trials
- Exploring the collection of audio and video evidence during clinical trials
- Using generated evidence to provide quantitative and qualitative data to evaluate the efficacy of novel treatments for patients
9:30 am Quantifying Digital Measures to Validate Digital Biomarkers for Parkinson’s Disorders
Synopsis
- Outlining strategy to develop digital measures to efficiently investigate Parkinson’s disease
- Objective measurement of task-based motor assessment using signal processing of wearable IMU data
- Evaluating digital measure clinical validity and sensitivity to disease progression
10:00 am Morning Break & Networking
10:30 am Considering Device Burden & Usability to Maximise Patient Compliance in Neurological Clinical Trials
Synopsis
- Identifying usability challenges and factors impacting device compliance
- Outlining strategies for minimizing usability challenges to reduce gaps in collected data
- Considerations regarding the use of less invasive data collection devices, e.g., non-wearable technologies
11:00 am Utilizing Wearable Technologies for Digital Clinical Measures of Activity & Gait
Synopsis
- Evaluating wearable devices at different body locations to measure gait metrics
- Balancing different device and location’s measurement performance and usability to select the device best fit for purpose
- Exploring applications of digital measures to a wide range of indications
11:30 am Demonstrating Fixational & Saccadic Eye Movements as an Objective Biomarker
Synopsis
- Reviewing the extensive neuropathoanatomy of fixational eye movements (FEMs), including microsaccades, tremor, and drift and their overlap with saccades and smooth pursuits
- Outlining the differences between involuntary microsaccades and voluntary saccades and how they can and cannot be manipulated by patient subjects
- Discussing the differences between pupil and retinal eye-tracking technologies and when each technology is best utilized
11:40 am Roundtable Discussion: Dissecting Development of Digital Measures Across CNS Clinical Development
Synopsis
Join tables led by digital biomarker experts to discuss the benefits and challenges of different digital measures of neurological disorders.
- Evaluating retinal eye motion as a prognostic biomarker for patient stratification and granular monitoring in CNS drug development
- Debating a standardized measurement package to streamline biomarker validation
- Balancing device and assessment sensitivity and usability to maximize quality of collected data
12:15 pm Lunch & Networking
UTILIZING PATIENT CENTRIC CO-CREATION TO DESIGN CLINICALLY MEANINGFUL DIGITAL MEASURES
1:15 pm Virtual Panel Discussion: Establishing a Dialogue to Understand Priorities & Experiences from Clinical Trial Participation for Digital Measures
Synopsis
- What are the priorities that participants are looking to get out of clinical trials for digital measures?
- Reflecting on experiences from recent clinical trials – what additional burdens did recording digital measures cause or alleviate?
- How can digital measures further accommodate the patient perspective moving forward?
1:45 pm Utilizing a Patient Centric Approach to Create Valuable Digital Measures
Synopsis
- Delivering value to patients and minimizing burden to drive adoption in data collection
- Integrating the patient perspective throughout the solution design process
- Using ChatGPT to kickstart patient design thinking: tips and pitfalls
2:15 pm Exploring a Digital Cognitive Assessment to Incorporate into Routine Patient Care
Synopsis
- Utilizing digital measures to rapidly quantify cognitive ability
- Outlining the ability of digital tools for early care and intervention
- Undertaking a patient-centric approach to relate real-world ability and routine care