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Abstract Details

Early engagement with the Alzheimer’s disease (AD) community to gain insights into designing the SKYLINE trial in cognitively unimpaired people at risk for progression due to AD
Aging, Dementia, Cognitive, and Behavioral Neurology
P5 - Poster Session 5 (11:45 AM-12:45 PM)
7-007

Recruiting cognitively unimpaired amyloid-positive older adults at risk for progression due to AD is challenging. Understanding their needs, concerns, and motivations for trial participation could help optimize participant identification and engagement and determine mechanisms to improve trial experience and retention. Actioning feedback from the target population during protocol development could make the trial more accessible and sensitive to a broad variety of participants, making recruitment easier and aiding retention by establishing a positive trial experience.

To gather insights from global Alzheimer’s disease (AD) community representatives to help customize clinical trial design to improve participant experience.

Advisory boards were held with two groups including CareRing; five Roche employees caring for people with AD, and representatives from twelve global AD advocacy organizations with diverse backgrounds, from multiple countries. Feedback was gathered on perceptions of the draft protocol design for SKYLINE, a global Phase III, multicenter study that was designed to evaluate the efficacy and safety of gantenerumab in participants at risk for or in the earliest stages of AD but stopped early (NCT05256134). Feedback received was incorporated into the SKYLINE protocol design.

Feedback highlighted the importance of three key areas to consider when conducting clinical trials in this population: 1. the importance of tailoring study materials and design to engage with a cognitively unimpaired, at-risk, or asymptomatic AD population and study partners, e.g., materials detailing trial expectations and home administration requirements; 2. flexibility of dosing options; 3. a sensitive and supportive disclosure process for brain amyloid status and apolipoprotein E genotype, along with guidance and training for site staff to ensure suitable support measures are available.

Collaboration with the AD patient advocacy community demonstrated the importance of early dialogue with target participant and study partner representatives to build patient-centric study designs with holistic supporting materials and processes.

Authors/Disclosures
Gesine Respondek, MD (Hoffmann-La Roche)
PRESENTER
Gesine Respondek, MD has received personal compensation for serving as an employee of Hoffmann-La Roche. Gesine Respondek, MD has stock in Hoffmann-La Roche.
Fiona Rose (Roche) Mrs. Rose has received personal compensation for serving as an employee of Roche. Mrs. Rose has stock in Roche .
Nancy Lynn, Other (BrightFocus Foundation) Ms. Lynn has nothing to disclose.
Jessica Langbaum, PhD Dr. Langbaum has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alector. Dr. Langbaum has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Denovo Biopharma. Dr. Langbaum has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. The institution of Dr. Langbaum has received research support from Eli Lilly.
Carolyn Langlois, Other (Banner Alzheimer's Institute) Ms. Langlois has received personal compensation for serving as an employee of Banner Alzheimer's Institute.
Emma Dodd Emma Dodd has received personal compensation for serving as an employee of Roche Pharmaceuticals. Emma Dodd has stock in Roche Pharmaceuticals.
Jannice Roeser Ms. Roeser has nothing to disclose.
Susanne Ostrowitzki (F. Hoffmann-La Roche) Dr. Ostrowitzki has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd. Dr. Ostrowitzki has stock in F. Hoffmann-La Roche Ltd.
Alexandria Wise-Brown, PhD (Genentech) Dr. Wise-Brown has received personal compensation for serving as an employee of Genentech.