Research into Alzheimer’s has intensified over the last forty years, and it has given us a significant depth of knowledge and insight into the disease. Yet despite some incredible progress, Alzheimer’s remains without a cure or effective treatment, and clinical trials are increasingly vital to the quest to beat the disease. However, successfully completing clinical trials for Alzheimer’s treatments, arguably, presents an even greater challenge than most other studies. One of the main reasons for this is the difficulty of recruiting eligible patients to take part in trials and enrolling them in sufficient numbers for trials to be seen through to completion. Recruitment has long been a significant challenge facing modern clinical research and this is perhaps most evident when it comes to Alzheimer’s trials.
Several studies conducted into Alzheimer’s research have identified three main factors which affect Alzheimer’s disease research participation and recruitment.
Firstly, there is the issue of obtaining referrals from primary care physicians. Someone with Alzheimer’s is less likely to be reached by traditional promotional materials and so generally Alzheimer’s trials rely on referrals. However, physicians often have a limited capacity to assess cognition, and they are not always kept well informed about locally active trials.
For this reason, it is vital that Sponsors and sites engage with local clinics and ensure that they inform practitioners about current and upcoming trials. Building relationships in this way will begin to bridge the gap between research and clinical care that is holding back recruitment for Alzheimer’s trials.
A second challenge to recruiting patients with Alzheimer’s is that studies often require a study partner to participate alongside the patient. This further complicates the recruitment process and makes it harder to recruit patients in sufficient numbers as two people need to be accommodated. Often it is a case of poor communication as there is an assumption that the study partner must be a spouse. However, research found that as many as 90% of Alzheimer’s patients don’t have a spouse. Instead, caregivers, children and Grandchildren are often eligible as study partners, but are not effectively targeted.
This problem can be solved through more effective marketing, using a clear message that the partner can be a caregiver or close family friend.
Utilising sites which are convenient and accessible for the target patient group is also a factor, as none-spousal caregivers are less likely to travel longer distances and inconvenience themselves to participate in a trial.
Thirdly there is the fact that Alzheimer’s disease research can require a number of relatively invasive procedures, such as lumbar puncture brain scans with radioactive materials. In many trials, these are part of the screening process before a patient can be accepted and enrolled, and the stressful nature of these can be off-putting to potential participants who may then withdraw.
To overcome this challenge, the atmosphere at sites, and the quality of the site staff are paramount. Sites are unfamiliar environments which can be extremely stressful for people with Alzheimer’s, and they should be made to feel as comfortable as possible. This can be done by site staff taking extra time to fully explain the trial and procedures to patients, as well as reminding them of the benefits of their participation and answering any questions. It is also helpful for the patient to receive several reminder/clarification calls from staff before a screening visit. Sponsors should also ensure that the sites themselves are dementia-friendly environments tailored to the specific needs of Alzheimer’s patients.
The Role of Technology
Technology also has an increasingly important role to play in helping recruit patients with Alzheimer’s for clinical trials. Online applications, forums and social media present an opportunity for eligible patients to be identified, contacted, pre-screened, and enrolled in trials far more quickly and effectively than traditional means. While some may think that Alzheimer’s patients are unlikely to use technology, at CitrusLabs we’ve have found this demographic to be incredibly active and engaged online, and also willing to participate in research. Our experience proves that online methods such as apps and websites may hold the key to transforming and improving the way patients are recruited, especially those with Alzheimer’s, on whom finding a treatment for the disease depends.