SearchDementia is a growing public health concern, affecting more than 55 million people worldwide, according to the World Health Organization.1 With nearly 10 million new cases diagnosed each year, the need for earlier detection and intervention has never been greater.1 In the United States, a 2025 Alzheimer’s Association report found that nearly 79% of adults would want to know if they had Alzheimer’s in its early stages, even when symptoms have yet to interfere with daily life.2
As the Alzheimer’s drug pipeline expands, clinical trials are moving toward earlier phases of disease progression, before symptoms appear, and cognitive decline begins. This shift creates new opportunities for early intervention but also presents a major challenge: identifying and enrolling the right patients before diagnosis is even on the radar.
Most individuals at this stage are undiagnosed, and without symptoms, they’re rarely referred to clinical trials. As a result, recruitment remains low, screen failure rates are high, and trial timelines are delayed, placing pressure on already limited site resources.
In our Advancing Alzheimer's Disease Therapies white paper, we explore how emerging biomarkers, digital tools, and more inclusive recruitment strategies are helping sponsors accelerate enrollment and giving people living with the disease earlier access to promising new treatments. Below are several key insights.
The Enrollment Bottleneck in Early-Stage Alzheimer’s Clinical Trials
While clinical trials are focusing more on early intervention, recruitment practices haven’t quite caught up. Early-stage patients often present with subtle or no symptoms, making them difficult to detect during routine care. Adding to the challenge, traditional diagnostic methods such as PET imaging and CSF analysis, though accurate, are not practical for broad application. These procedures are costly, invasive, and require specialized infrastructure that many sites simply don’t have.
To close this gap, trials need more accessible, scalable screening tools that reduce patient burden and can be integrated into primary care settings, ideally allowing for earlier identification during routine check-ups.
Biomarker Innovation Is Expanding: What’s Possible
Today, blood-based biomarkers are changing how we approach early detection in Alzheimer’s disease. Plasma assays targeting markers (i.e., p-tau181, pTau217, and GFAP) closely mirror the performance of traditional diagnostics, offering a simple and less invasive alternative. The FDA’s Breakthrough Device designations for Elecsys® pTau217 and Simoa® pTau217 show just how quickly these tools are gaining momentum in clinical settings.
These assays offer something conventional diagnostics couldn’t: scalability and ease of use. With the potential to be integrated into routine care, they could broaden Alzheimer’s screening and support earlier, more widespread identification of at-risk individuals.
For sponsors, incorporating plasma biomarkers into screening protocols can accelerate enrollment, reduce screen failure rates, and improve trial efficiency.
Extending Access and Reducing Burden with Digital Tools
Just as biomarkers are making screening more accessible, digital health technologies are helping expand what’s possible in ongoing monitoring and assessment. Remote cognitive testing, speech analytics, and wearable sensors are now being evaluated as digital biomarkers, offering new ways to track cognitive and functional changes over time.
For example:
- At-home cognitive assessments, modeled on tools like the ADCS Preclinical Composite, are being validated for long-term monitoring.
- AI-based speech and behavior analysis may detect early cognitive shifts that would otherwise go unnoticed.
- Wearable devices offer continuous, low-burden tracking of physical activity, sleep, and other functional metrics.
These technologies are promising in early-stage populations, where symptoms may be minimal and traditional site-based evaluations may not be sensitive enough to detect change, but they require further development.
Addressing Disparities in Recruitment
Despite having a higher risk for Alzheimer’s, Black and Hispanic adults remain under-represented in clinical trials. This lack of representation limits the generalizability of results and leaves important questions unanswered about how therapies perform across different populations.
Improving representation requires more than inclusive messaging. It takes community-centered strategies and optimized site selection. That includes partnering with local organizations, supporting sites in historically underserved areas, and collaborating with trusted providers who reflect the communities they serve.
Smarter Trial Designs for Smarter Therapies
Recruitment isn’t just about finding eligible patients; it’s also about making participation easier.
Overly complex protocols and rigid visit schedules can lead to high dropout rates and underpowered results. To address this, sponsors are turning to adaptive platform designs, biomarker-guided enrollment, and shared infrastructure that make trials more accessible and centered on the patient and caregiver.
Conclusion
It is estimated that 33 million to 39 million people globally are currently living with Alzheimer’s disease, and that number is rising3. With the new therapies to gain approval and earlier intervention set to become the standard of care, clinical trial strategies must evolve. That means finding patients sooner, reducing barriers to participation, and designing studies that reflect real world needs. Well-structured trials not only support better data, but they also improve the patient experience, reduce dropout rates, and accelerate go/no-go decisions, reducing safety risks.
At IQVIA Biotech, we’re helping sponsors rethink recruitment for Alzheimer’s clinical trials, from biomarker-driven screening and digital monitoring to decentralized infrastructure and community-based outreach. Because accelerating early-stage Alzheimer’s clinical research isn’t just about moving faster – it’s about reaching the people who need it when it can make the most difference.
World Alzheimer’s Day is September 21. Let’s commit to advancing early detection, improving patient outcomes, and building clinical research that truly makes a difference.
To explore how these strategies can support your next study, download our white paper: Advancing Alzheimer’s Disease Therapies: How Biotech Sponsors Can Accelerate Clinical Development of Early Stage Interventions
Contact us to learn how IQVIA Biotech can support your Alzheimer’s disease clinical trial.