June is Alzheimer’s & Brain Awareness Month, a time to recognize the impact of Alzheimer’s disease and the urgent need for continued research. With more than 55 million people worldwide living with dementia, and Alzheimer’s disease remaining the most common cause, the demand for effective treatments has never been greater. Yet despite significant scientific advances, patient recruitment continues to be one of the leading causes of delays in Alzheimer’s clinical trials and in bringing new treatments to market.
For sponsors, CROs, and research sites alike, recruitment challenges have evolved considerably in recent years. Traditional barriers such as caregiver dependency, treatment hesitancy, and digital accessibility remain highly relevant, while emerging factors, including early-stage patient identification and biomarker-driven eligibility criteria, are shaping recruitment strategies across the industry.
In this blog, we examine the five most significant challenges affecting Alzheimer’s patient recruitment today and explore practical approaches to overcoming them.
1. Finding Alzheimer’s patients early enough for enrollment
One of the biggest challenges in Alzheimer’s patient recruitment today is identifying eligible patients in the early stages of the disease. As research increasingly shifts toward earlier intervention, many clinical trials now focus on individuals with mild cognitive impairment (MCI), prodromal Alzheimer’s disease, or those who are biomarker-positive but experiencing few noticeable symptoms.
The challenge is that many people remain undiagnosed until cognitive decline has become more advanced. Delayed diagnosis can significantly reduce the pool of eligible participants, particularly for studies investigating disease-modifying therapies designed to intervene before substantial neurological damage occurs. At the same time, eligibility criteria have become more complex, often requiring specific cognitive assessments, disease staging, and biomarker confirmation before enrollment.
As a result, recruitment has evolved from simply finding Alzheimer’s patients to identifying the right patients at the right stage of disease progression. The importance of early identification has been widely recognized across the industry, with experts highlighting earlier diagnosis, improved access to research opportunities, and greater inclusivity as key factors for accelerating Alzheimer’s trials.
How sponsors can address this challenge
Sponsors can improve recruitment outcomes by investing in early patient outreach, strengthening partnerships with patient organizations, MedTech apps, and research experts, developing referral pathways from primary care, and supporting awareness initiatives focused on the early signs of cognitive decline. The earlier eligible patients can be identified, the greater the opportunity to accelerate enrollment and reduce recruitment delays.
2. Caregiver dependency: Why each patient enrolled typically requires the consent of two people
Alzheimer’s disease often requires enrolling a second individual as well, the patient’s dedicated care partner. Caregivers may be responsible for accompanying patients to study visits, completing cognitive and behavioral assessments, monitoring treatment adherence, and providing observational data to investigators.
This creates a unique recruitment challenge. Research has shown that patients with dementia are less likely to participate in clinical trials when their primary caregiver is not a spouse. In many cases, the barrier is not a lack of willingness to participate, but logistics. Patients with Alzheimer’s disease who do not require continuous support are often cared for by adult children, relatives, or friends who may live separately and balance work, family, and other responsibilities.
From Clariness’ experience of supporting Alzheimer’s clinical trial recruitment for over 20 years, transportation is one of the most common barriers preventing otherwise eligible patients from enrolling. Challenges are particularly common when caregivers do not live nearby or are unable to consistently accompany patients to study visits.
How sponsors can address this challenge
Successful recruitment strategies should engage caregivers as a primary audience, clearly communicate study expectations, and minimize the participation burden through flexible scheduling, travel support, and patient-centric study designs. Creative trial materials should also be developed with both patients and caregivers in mind, clearly explaining the roles, responsibilities, and time commitments expected of each throughout the study journey.
Hybrid and decentralized clinical trial models can reduce the number of required site visits, helping patients participate without relying heavily on caregivers for transportation. For studies that still require in-person visits, such as those involving PET scans, transport support can help remove a major logistical barrier. To address this challenge, Clariness works with a network of trusted partners to help facilitate patient travel and site access, reducing the logistical burden on patients, caregivers, and study sites while supporting participation throughout the clinical trial journey.
3. Reluctance to discontinue or change existing medication
Historically, one of the biggest recruitment challenges in Alzheimer’s clinical trials was patients’ reluctance to stop taking established medications in favor of investigational treatments. Today, the landscape has become even more complex as new approved therapies expand treatment options for some patients.
For patients and caregivers, the decision to participate in a clinical trial can be difficult. Even when existing treatments offer only modest or temporary benefits, they provide a sense of familiarity and stability. Concerns about receiving a placebo, changing treatment routines, or trying a therapy with unknown outcomes can make clinical trial participation feel risky.
This hesitation is understandable. In a disease where preserving cognitive function and independence is critical, patients are often cautious about making changes to their care.
How sponsors can address this challenge
Clear, patient-centric education is essential. Recruitment materials should explain the purpose of the study, potential risks and benefits, and how participation fits within the broader Alzheimer’s treatment landscape. This is particularly important in Alzheimer’s disease, where many patients and caregivers may be hesitant to change established treatment routines or participate in research involving placebo-controlled clinical trials.
Our survey data shows that altruism is the second biggest driver of clinical trial participation across all indications, with the primary motivator being the hope of finding a treatment that improves or cures their own condition, of course. This highlights the importance of educating patients and caregivers about their current treatment. While existing Alzheimer’s therapies mostly manage symptoms, there remains a significant unmet need for treatments that can slow, stop, or reverse disease progression. Helping patients understand this reality can reinforce the value of clinical research, not only for themselves, but for others living with Alzheimer’s disease today and future generations who may develop the condition.
Transparency around study design is equally important. Patients and caregivers should understand whether a study is placebo-controlled and what that means for their participation. In studies without a placebo arm, participants can be reassured that they will receive active treatment. In placebo-controlled studies, explaining the scientific rationale behind the design can help address concerns and build trust, especially if coupled with information about the efficacy of existing treatments on the market. Ultimately, clear communication empowers patients and caregivers to make informed decisions about participation and can help improve recruitment and enrollment outcomes.
4. The evolution of digital literacy challenges
Digital channels have transformed patient recruitment, enabling sponsors to reach and engage potential participants on a global scale. However, Alzheimer’s disease primarily affects older adults, many of whom are less comfortable using smartphones, computers, social media, and other digital tools.
In a new European study named ‘Closing the confidence gap: how older adults navigate the digital world’ in collaboration with the Vodafone foundation, it found that 91% of older adults use digital devices daily, yet 69% report low confidence or fear of making mistakes. Research shows that older individuals often require support when using new technologies and may be reluctant to engage online due to concerns about making mistakes or navigating unfamiliar platforms.
This creates a significant recruitment challenge. Even when patients are reached through digital campaigns, they may struggle to complete online pre-screeners, locate nearby study sites, or contact research staff. As a result, patients can abandon the enrollment process before reaching a study site.
How sponsors can address this challenge
For Alzheimer’s trials, successful digital recruitment requires understanding where patients and caregivers go for research, education, and cognitive engagement. This may include health information websites, memory apps, brain training platforms, and even Sudoku or puzzle sites, allowing sponsors to reach participants in environments they already know and trust.
However, reaching patients online is only the first step. The recruitment journey itself must be simple, accessible, and designed around the needs of older adults and their caregivers. One effective approach is a two-step screening process, where patients are initially asked to provide only basic, low-risk information through a short online screener. This helps reduce concerns about making mistakes or sharing sensitive information too early in the process.
Patients then speak with one of our protocol-trained enrollment specialists at their preferred time or within one hour of registering to learn more about the study and complete more detailed pre-screening. This human interaction helps build trust, provides an opportunity to answer questions, and allows patients and caregivers to feel more comfortable sharing additional information.
Recruitment journeys should also support caregiver involvement through caregiver-enabled screening pathways, dual patient-caregiver communications, study materials tailored to both audiences, and clear explanations of each person’s role and commitment throughout the trial. Without a patient-centric approach, digital recruitment campaigns risk losing eligible participants due to frustration, confusion, or unnecessary complexity.
5. Biomarker qualification is creating a new recruitment funnel
One of the most significant shifts in Alzheimer’s clinical research is the growing reliance on biomarkers to identify eligible participants. Biomarker research has revealed that Alzheimer’s disease can begin 20 years or more before symptoms appear, driving a growing focus on earlier intervention and more targeted patient selection.
According to the Alzheimer’s Disease Drug Development Pipeline: 2025, 57% of Alzheimer’s trials in 2025 used biomarkers as part of their eligibility criteria. Common requirements now include brain scans, spinal fluid tests, and blood tests that help confirm the presence of Alzheimer ’s-related changes in the brain.
While biomarkers help identify patients most likely to benefit from investigational therapies, they also create a new recruitment funnel. Patients may respond to a recruitment campaign, pass initial screening, and complete clinical assessments, only to be excluded after biomarker testing. This can increase screen-failure rates and extend recruitment timelines.
How sponsors can help address this challenge
Successful recruitment planning must account for the entire biomarker journey, not just initial referrals. Sponsors should anticipate screen failures, educate participants about biomarker requirements early in the process, and build recruitment strategies that accommodate additional screening steps. Emerging blood-based biomarkers may help streamline this process in the future by enabling earlier, less invasive, and more scalable identification of eligible patients.
Real-world Alzheimer’s recruitment success
With two decades of experience recruiting patients for Alzheimer’s disease clinical trials, Clariness has helped sponsors overcome complex enrollment challenges and connect with eligible participants. Here are two Alzheimer’s case studies:
Case Study: 166% randomization target achieved in just 3 months
Supporting enrollment for a Phase II/III Alzheimer’s disease study through an online patient recruitment campaign spanning 40 sites across 5 countries.
Our approach:
- Implemented a targeted online recruitment strategy combined with online and phone pre-screening to identify highly qualified patients
- Provided active site support to contact, process, and enroll referred patients, reducing site workload and improving efficiency
Our results:
- 166% of planned randomizations achieved
- 1,740 pre-screened referrals delivered in just 3 months
- 36% reduction in cost per randomized patient via ClinLife®
- Recruitment targets exceeded while utilizing only 64% of the allocated budget
Case Study: 1 in 3 referrals randomized for a decentralized dementia study
An international virtual dementia study requiring both 99 patients and caregiver participation, conducted across multiple countries following a transition to a decentralized trial model.
Our approach:
- Leveraged ClinLife® to identify and engage eligible patients and caregivers for a fully virtual study
Our results:
- More than 20% of randomized study pairs were delivered through ClinLife®
- Achieved 110% of the committed randomization target
- 1 in 3 referred patient-caregiver pairs were randomized
Take a look at what our client from FHWS said:
“When we published our study on ClinLife®, it was magic. We didn’t have to do anything, and suddenly we had a list of interested participants!”
Advancing Alzheimer’s clinical trials through smarter recruitment
At Clariness, we’ve spent more than two decades helping sponsors and CROs navigate the complexities of patient recruitment across neurological studies.
As Alzheimer’s & Brain Awareness Month reminds us, accelerating recruitment is about more than meeting enrollment targets – it’s about helping bring the next generation of therapies to patients and families faster. By adopting patient-centric, data-driven recruitment strategies, sponsors, CROs, and sites can help overcome these barriers and keep critical Alzheimer’s research moving forward.
Improve recruitment for your next Alzheimer’s study with Clariness
Author: Mercy Hapsiba, Content Marketing Specialist, Clariness | Post Date: 11.06.2026