Studies of investigational drugs targeting the dementia stage of Alzheimer’s disease (AD) have used a co-primary approach to assess cognitive and functional (or global) measures. This approach ensured both a clinically meaningful effect by a demonstration of benefit on the functional measure and that the observed functional benefit was accompanied by an effect on the core symptoms of the disease as measured by the cognitive assessment. This webinar will examine how endpoint strategy, rater training and eCOA delivery can support data quality in Alzheimer’s Trials as studies move into earlier disease stages.
As the scientific understanding of AD has evolved, enrollment of patients with AD at earlier stages, where there may be no functional impairment or even no detectable clinical abnormality, has become possible and desirable to delay or halt the disease at the earliest opportunity.
Because disease manifestations are highly variable in early-stage AD, clinical trials in this population require different clinical assessments and/or novel endpoints to effectively capture and demonstrate treatment benefit. In addition, the complexity of measurement methods required in early-AD requires strategic approaches to rater training and data integrity across global, decentralized study environments. Early missteps, whether in assessment selection, rater selection or operational execution, can compromise data quality and lead to loss of signal.
This webinar will examine the science-first foundations of early-stage AD protocol design, including considerations around which cognitive endpoints can be utilized, operationalized and protected in the absence of overt cognitive impairment. The discussion will connect this scientific strategy to study execution, highlighting how expert rater training and monitoring, combined with flexible eCOA delivery, are critical to preserving endpoint data quality.
Register for this webinar to learn how scientific strategy, eCOA delivery and rater training can help protect endpoint integrity in Alzheimer’s trials.
Speakers
(Moderator) Scott Neff, Regional Vice President, Business Development, Clinical ink
Scott Neff has led global sales teams and initiatives looking across a broad platform of needs for Biotech and Pharmaceutical companies. He has been guiding customers through FDA regulations, helping them better understand how to deploy site and patient friendly technologies to increase participation and compliance.
Message Presenter
David Anderson, Senior Director, Science and Innovation, Clinical ink
Dr. David Anderson is the Sr. Director of Science & Innovation at Clinical Ink, where he builds the company’s AI & Innovation ecosystem and leads cross-functional teams spanning Applied AI, Connected Devices and Data Science. He directs Clinical Ink’s Innovation Lab and drives innovative data pipelines that turn raw sensor and eCOA data into regulatory-grade digital biomarkers and near–real-time insights for sponsors and sites. Dr. Anderson’s work integrates wearables and smartphone sensors with modern data platforms to deliver scalable analytics and patient-centric outcomes. He has spearheaded initiatives around cognition, speech and mobility, and partners closely with academic and pharma collaborators to translate research into production.
Dr. Anderson is a Neuroscientist by training and education with over twelve years of experience developing hardware and software solutions to evaluate human behavior and physiology in both laboratory and real-world environments.
Message Presenter
Megan Petrylak, Chief Operating Officer, Clinical ink
With over 17 years of clinical trial experience, including 14 years in operational leadership roles, Megan Petrylak plays a key role at Clinical ink. She oversees all customer, site and patient-facing operations, enhancing Clinical ink’s capabilities in data management and quality assurance. Her commitment to fostering a quality-first culture has led to remarkable improvements in customer satisfaction, reduced study build and execution times and outstanding quality outcomes.
Megan has a proven track record in driving successful Phase I-III clinical trials for a diverse range of global biopharmaceutical companies and contract research organizations (CROs). Before joining Clinical ink in 2018, she served as Director of Project Delivery at Worldwide Clinical Trials and previously led Bioclinica’s eClinical project management and support services. Beyond her extensive expertise in eCOA, project management and data management, Megan is a dedicated team builder who believes that exceptional customer satisfaction begins with nurturing and supporting employees.
Message Presenter
Edward I. Bartolic, PhD, Senior Director, Clinical Science, Cogstate
Edward I. Bartolic, PhD, is a Senior Science Director at Cogstate and a Clinical Neuropsychologist with 20 years of postdoctoral clinical research experience.
Dr. Bartolic has held various scientific positions within global contract research organizations and has served as a Clinical/Therapeutic Lead, overseeing the development and management of Global Rater Training and Data Monitoring/Rater Surveillance programs for studies in Psychiatry and Neurology. He has served as a Lead Rater Trainer at numerous investigator meetings for studies across CNS indications. He has designed customized methodologies for remote monitoring of clinical trial assessments.
Dr. Bartolic graduated from the University of Cincinnati with a PhD in Clinical Psychology and specialization in Neuropsychology.
Message Presenter
Who Should Attend?
This webinar will appeal to pharma, biotech and CROs responsible for the clinical development of Alzheimer’s disease therapeutics, including:
- Clinical Operations Leads
- Clinical Scientists and Neuropsychologists
- CNS/Neurology Programs Leads
- Regulatory and Quality Assurance Professionals
- Biostatisticians and Clinical Data Management
- Digital Health and Innovation Teams
- Medical Affairs and Translational Research
- Outsourcing and Procurement
What You Will Learn
Attendees will gain practical insight into how scientific strategy and operational execution must align to preserve data quality and endpoint integrity across global early-stage Alzheimer’s trials, including:
- How to select and apply the right cognitive and functional endpoints for populations where overt impairment may be absent
- Best practices for rater selection, training, monitoring and remediation to ensure reliability and consistency throughout the study
- How flexible eCOA delivery with BYOD and provisioned device support enables complex cognitive and patient-reported assessments while maintaining real-time data visibility and regulatory readiness
- Advanced approaches to digital assessments and analytics, including cognitive batteries and voice analytics, and their role in capturing treatment benefit in early-stage populations
Xtalks Partner
Clinical ink
Clinical ink is a global life science company bringing data, technology, and patient-centric research together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, behavioral and dropout prediction, eConsent, telehealth, and digital biomarkers advancements, including use of Continuous Glucose Monitoring for detection of hypoglycemia, support the next generation of clinical trials and ultimately the clinical management of patients.
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account