Clinical Matters: Recruiting and Retaining Alzheimer’s Patients for Clinical Trials
An estimated 6.2 million Americans aged 65 and older are living with Alzheimer’s disease. This number could grow to 13.8 million by 2060, the Alzheimer’s Association reports, barring the development of medical breakthroughs to prevent, slow, or cure the disease.1 Furthermore, between 2000 and 2019, deaths from stroke, heart disease, and HIV decreased, whereas reported deaths from Alzheimer’s increased by more than 145%—which has likely been exacerbated by the COVID-19 pandemic.1,2
Without intervention, the impact of Alzheimer’s disease to patients, their caregivers, and the medical and science communities will continue to grow exponentially. The logical path forward is expanded research and development. September is World Alzheimer’s Month, and, for many of us in life sciences and pharmaceuticals, it serves as an important reminder of the urgency of developing treatments and remaining committed to finding a cure.
Yet one challenge is often overlooked: recruiting enough eligible participants, coordinating site visits, and retaining patients throughout the length of an Alzheimer’s study. Truthfully, these hurdles are present in nearly all trials—but Alzheimer’s disease presents unique circumstances that affect trial participants and logistics.
With greater understanding of the challenges facing patients, caregivers, and physicians, researchers can better structure Alzheimer’s disease studies to minimize barriers and improve participation. This is essential because without clinical trials, we would have no treatments and make no progress toward prevention or a cure.
Unique Circumstances Surrounding Alzheimer’s Trials
Many studies require that participants be in otherwise good health, which is uncommon in an aging population. In fact, Alzheimer’s disease is frequently linked with cardiovascular disease, which often disqualifies a patient from eligibility.3 Additionally, some heart and blood circulation problems, stroke, and diabetes are more common in people who have Alzheimer's than in the general population.4
Diseases caused by infections are also common. Compounding these health issues, people with Alzheimer’s often experience confusion and behavior issues as a result of their disease.5 The patient more easily may become upset, worried, or angry.
Extenuating factors such as pain, medication use, and lack of sleep can also alter the patient’s personality in a way that is frustrating to both the patient and the caregiver. In addition, a patient’s surroundings—loud or constant noise, such as from a TV or radio or nearby people—can affect behavior negatively. Unpaid caregivers are typically not attuned to or trained in the many factors that will influence a patient’s daily behavior, much less their willingness to participate in clinical trials—even when the patient may have demonstrated initial interest.
Ideally, a patient will be supported by a patient coordinator who can minimize the burden of participation by managing logistics and advocating for the patient throughout the clinical trial.
Besides having an awareness of these challenges, a patient coordinator can help navigate the additional complications facing patients with Alzheimer’s disease, such as the following:
• Cognition: Cognitive abilities in Alzheimer’s patients can deteriorate rapidly, while trial timelines are typically years in length. As cognitive faculties decline, the level of support patients need increases. Simultaneously, their willingness to participate and understand the purpose of the study may decrease or be forgotten altogether. Even without the challenge of having Alzheimer’s, older patients are generally not as tech-savvy as younger trial participants, so communicating via e-mail or a patient portal may not be an option.
• Finances: Many older patients are on a fixed income, making any travel or transportation expenses related to site visits especially burdensome. Prompt reimbursement is crucial, but, as noted above, cognition issues can make online pay portals very challenging for these patients to use. Many would be better served by prepaid travel arrangements.
• Mobility: Older patients often prefer not to leave their homes, much less travel to unfamiliar locations. Alzheimer’s patients can be quickly overwhelmed by new places, particularly large and confusing locations such as airports or rail stations. Many prefer traveling by car, which can mean extended ground transportation to research sites. And given the advanced age of the patient population, long periods of car travel can be physically taxing and require frequent stops for stretching and bathroom breaks.
• Logistics: Travel by car requires extensive advance planning to ensure the patient’s comfort and safety. The vehicle must accommodate equipment needs, such as a wheelchair, walker, or braces. Each leg of the journey must be carefully choreographed to accommodate frequent stops, and if the distance from home to site is great, overnight stays may be necessary. When this is the case, additional planning is necessary to ensure that appropriate hotels are available along the way with rooms prebooked for the patient, caregiver(s), and, in some cases, drivers. Weather, traffic, and road construction can interfere with arrival time and must also be anticipated.
All of these issues can be addressed by dedicated patient coordinators, who often work with participants and their caregivers for the duration of the trial. Coordinators provide personalized support for travel, financial prepayments or reimbursements, relocation services, and more. This service requires that the trial’s pharmaceutical sponsor and/or contract research organization recognize the unique challenges facing patients with Alzheimer’s and invest in an experienced partner to manage the trial’s logistics.
The Role of Physicians and Patient Caregivers in Clinical Trials
One study estimates that the dropout rate for Alzheimer’s clinical trials can be as high as 38% for patients who enroll with an adult child and 36% for patients who enrolled with a partner who was neither a spouse nor a child.7
Physicians are a critical resource for patient families and caregivers. An Alzheimer’s patient’s primary care physician can make an initial diagnosis or refer the patient to a specialist, such as a geriatric nurse practitioner, geriatric psychiatrist, gerontologist, or neurologist, for a diagnosis or support services (caregiver classes, support groups, behavior management, etc). However, making these connections will be contingent on the resources and knowledge of the caregiver.
Some caregivers who have a background or interest in medicine and health care will conduct their own research and find available trials. Often they will reach out to the patients’ primary care physicians or other medical care providers for more information on the trial and how to enroll. But the capacity of the caregivers to enroll the patient in clinical trials, much less provide a smooth trial experience, is limited by their own circumstances.
Caregivers may be aging spouses who have their own medical challenges. In the absence of a spouse, the caregiver role may fall to a child or other family member who must juggle conflicting priorities, including the demands of family and work. The additional burden of participating in a trial can be an overwhelming proposition.
In fact, unpaid dementia caregiving was valued at $256.7 billion in 2020. Its costs extend to family caregivers' increased risk for emotional distress and negative mental and physical health outcomes—costs that have also been aggravated by COVID-19.2
Investments in paid caregiver support as well as high-quality patient care have a dramatic impact on the Alzheimer’s population. Additionally, partnering with patient support coordinators trained in managing expenses and itinerary logistics enable caregivers to focus on the patients’ health. Working together, support providers can significantly improve clinical trial recruitment and retention.
How Clinical Trial Support Services Affect Recruitment and Retention
Retention becomes increasingly difficult in Alzheimer’s clinical trials as the patient moves along the trial spectrum. All Alzheimer’s trials require the participation of a study partner, who will facilitate participation, reporting, and monitoring during the trial.8 The study partner must accompany the patient to site visits and make regular reports on the patient’s cognitive and functional abilities for the duration of the study, which can last for several years.
Offering patient support services is a proactive, effective strategy for managing the particular challenges of the Alzheimer’s patient population. Navigating Alzheimer’s is demanding and heartbreaking, so enlisting patient support services reduces the perceived burdens of trial participation.
Knowing they will be supported in these areas encourages both patients and caregivers to enroll, while ongoing support enables long-term participation. Beyond easing the health, cognitive, financial, and logistical challenges that often limit participation in clinical trials for Alzheimer’s patients, patient coordinators build personal relationships with the patient and their caregivers.
By providing direct support to participants from enrollment through the end of a clinical trial, logistics management companies establish and maintain a sense of trust between participants, caregivers, and site staff, thereby improving the patient’s experience. Furthermore, eliminating the burden of logistics reduces the pressure placed on clinical trial staff. Most important, positive outcomes in Alzheimer’s clinical trials today will lead to more treatments and, hopefully, a cure.
— Scott Gray is founder and CEO of Clincierge, the leader in patient logistics management for clinical trials. He’s a recognized leader in the world of medical meetings and patient-centered clinical trial support. For more information, visit clincierge.com.
2. Facts and figures. Alzheimer’s Association website. https://www.alz.org/alzheimers-dementia/facts-figures. 2021. Accessed June 3, 2021.
3. Tini G, Scagliola R, Monacelli F, et al. Alzheimer’s disease and cardiovascular disease: a particular association. Cardiol Res Pract. 2020;2020:2617970.
4. Alzheimer’s disease: common medical problems. National Institute on Aging website. https://www.nia.nih.gov/health/alzheimers-disease-common-medical-problems. Updated May 18, 2017.
5. Managing personality and behavior changes in Alzheimer’s. National Institute on Aging website. https://www.nia.nih.gov/health/managing-personality-and-behavior-changes-alzheimers. Updated May 17, 2017.
6. Considerations for improving patient recruitment into clinical trials. Clinical Leader website. https://www.clinicalleader.com/doc/considerations-for-improving-patient-0001. Accessed June 3, 2021.
7. Bernstein OM, Grill JD, Gillen DL. Recruitment and retention of participant and study partner dyads in two multinational Alzheimer’s disease registration trials. Alzheimers Res Ther. 2021;13(1):16.
8. Alzheimer’s disease fact sheet. National Institute on Aging website. https://www.nia.nih.gov/health/alzheimers-disease-fact-sheet. Updated July 8, 2021.