Down Syndrome  and Alzheimer’s  Clinical Trial Recruitment Case Study

In the Down syndrome community, Alzheimer’s disease presents a uniquely  challenging health concern. Adults with Down syndrome face a significantly higher risk of developing Alzheimer’s disease compared to the general population – with studies indicating that by age 60, approximately 50–70% of individuals with Down syndrome show signs of dementia. This elevated risk stems from the genetic connection: the extra copy of chromosome 21 leads to increased production of amyloid precursor protein, which contributes to the formation of amyloid  plaques characteristic of Alzheimer’s disease.

When our agency partnered with a leading pharmaceutical company conducting a groundbreaking Alzheimer’s clinical study focused on individuals with Down syndrome, we encountered a fundamental communication challenge. Traditional clinical trial materials, with their complex medical terminology and dense information presentation, were not effectively serving this special population. The research team needed educational resources that would truly empower potential participants to understand the study process, their rights, and what participation would entail – all presented in a way that respected their cognitive differences while maintaining complete accuracy to the protocol.

Our task was to develop a comprehensive suite of awareness and educational materials specifically tailored to the cognitive and learning profiles of adults  with Down syndrome. This required reimagining how clinical information could  be communicated with clarity, accessibility, and dignity, while still meeting all  regulatory and ethical requirements for informed consent.

Develop Cognitively Accessible Educational Materials
+   Create a comprehensive suite of study materials tailored to the learning profiles of individuals with Down syndrome
+    Implement clear, concrete language with consistent terminology and step-by-step information about study participation
+   Accommodate varying literacy levels and processing speeds while maintaining clinical accuracy

Ensure Authentic and Empowering Representation
+   Visually represent the Down syndrome community with dignity and authenticity
+   Showcase genuine diversity within the Down syndrome community
+   Feature individuals of various ages, ethnicities, and abilities as active clinical research participants

Implement Accessible Design Techniques
+   Employ high-contrast colors and visual cues to enhance comprehension
+   Utilize thoughtful typography and layout principles for cognitive differences
+   Create simplified diagrams translating complex medical procedures into understandable steps

Support Caregiver Partnerships
+   Develop parallel materials facilitating caregiver involvement without diminishing participant autonomy
+   Equip caregivers with supplementary information and conversation guides  to support understanding

Evidence-Based Foundation
+   Conducted comprehensive secondary research on cognitive processing in individuals with Down syndrome
+   Analyzed existing health literacy studies specific to neurodivergent populations
+   Examined effective communication approaches from fields like special education
+    Reviewed published case studies on successful participant engagement in similar patient populations

Assumption-Free Design Process
+   Set aside traditional clinical trial communication frameworks
+   Abandoned preconceptions about simplification versus comprehensiveness
+   Questioned industry norms about what information “must” be presented first
+   Developed materials that focused on the needs of potential study participants

Show, Don’t Just Tell
+   Created visual narratives showing the complete study participant journey
+    Developed clear illustrations depicting key step-by-step medical processes
+    Implemented color-coding systems to distinguish different aspects of the study

Key Opinion Leader Collaboration
+   Partnered with leading Down syndrome advocacy organization to review and  advise on material development
+   Consulted with the sponsors medical director who specialized in working with neurodivergent populations
+   Consulted communication experts from the disability rights community  throughout the process

Enhanced Understanding & Informed Participation
+   94% of participants demonstrated accurate comprehension of key study elements
+   Participants reported feeling “prepared” and “confident” about their role in  the research initiative
+   Retention rates exceeded expectations with 87% participant completion  of all study visits

Caregiver & Clinical Site Impact
+   Site coordinators reported 72% reduction in time spent explaining study concepts
+   Caregivers noted significant improvement in their ability to support decision-making
+   Communication materials became reference tools used throughout the study

Recognition & Broader Influence
+   Study materials received commendation from IRB for the accessibility of content
+   Materials framework was adapted for three additional clinical trials
+   Approach established as a model for inclusive clinical trial design within the  sponsor’s organization

Through our dedicated focus on cognitive accessibility and respectful engagement, we developed clinical trial materials that created genuine connections with the Down syndrome community. This human-centered methodology, paired with our evidence- driven design approach, enhanced how individuals with Down syndrome experience participation in clinical research.

The evidence speaks volumes about our impact: understanding of key concepts reached unprecedented levels and participation milestones exceeded all expectations. Yet beneath these quantifiable successes lies something even more valuable: creating pathways to meaningful inclusion in critical Alzheimer’s research for a population that has long faced systemic barriers.

This initiative demonstrates that when specialized expertise aligns with thoughtful implementation, we can significantly elevate research quality while preserving the
dignity and agency of each participant. We’ve created a pioneering framework for clinical communication – one that harmonizes accessibility principles with scientific rigor and ethical excellence.

Impact at a Glance
+   Near-universal comprehension of essential study components
+   Dramatic improvement in informed consent process engagement
+   Exceptional participant continuation throughout the research journey