September is Alzheimer’s Awareness Month. Alzheimer’s disease is the most common form of dementia, affecting nearly 40 million people worldwide. With more than 140 drugs in the biopharmaceutical pipeline, a future with more effective treatments and disease prevention is more promising than ever. In spite of a robust pipeline and recent breakthroughs, clinical research involving Alzheimer’s disease patients is complex and presents many different challenges to manage. We spoke with Dolly Niles, Executive Director of QUEST Research Institute about these challenges and opportunities to radically change how Alzheimer’s patients are treated and cared for.
Tell us about QUEST and how the institute developed its specialization in neurology and Alzheimer’s Disease (AD)? QUEST has been providing research opportunities to metro-Detroiters for over 25 years. We have always had a strong focus on neurological conditions, and it has been 30-50% of our trial docket for over 20 years. However, the team has also adapted and developed clinical research specialties to meet our community’s needs as well helping to find better treatments for common conditions like arthritis, hypertension and even cancer. When we first started AD research, study designs were exceedingly difficult and required significant training of our clinical staff. It was clear we needed to build expertise in memory loss research when the forecast of AD predicted impacting more than 10% of people over the age of 65. That is a huge burden on the community and health care system. We wanted to offer these trials locally, as quickly as possible, to improve the treatments (only three!) available then. QUEST is continuing to build capacity and specialization. Recent facility expansions will more than double our current research space to 10,000 square feet.
After years of well-publicized clinical trial failures, AD research finally received a breakthrough with the approval of Leqembi, the first medication that has been shown to slow disease progression. Has this news positively impacted clinical trial interest and recruitment response? This treatment and other medications in this class that are currently in development are the first disease modifying treatments that do not just treat symptoms. We hope to be giving people with Alzheimer’s longer, more productive lives. The current treatments also have room for improvement, and we need to continue completing these clinical trials to advance these medicines.
How do you find potential participants? What have been the most successful recruitment techniques? At QUEST we try to host community events and “lunch-and-learns” to educate people about brain healthy habits and the role clinical research should take as a facet in everyone’s healthcare spectrum. We share symptoms to be concerned about versus normal aging and offer free memory screens for those who are interested. Lastly, joining our mailing list for timely notifications of a new study or news about memory research is the way to stay engaged long term.
What do you see as the greatest challenges in conducting AD clinical trials and how has the Quest team overcome these challenges? Many people do not realize that participating in a trial is free to them and a way to feel they are taking control of their condition. It also is a bit of work for patients and their caregivers (study partners) to participate in a study, but many of our trials provide transportation and a stipend. Lastly, it can also be difficult for them to find a study partner (or they do not want to be an inconvenience and ask someone) so we always ensure the study partners also receive a stipend for their time and participation. Our Patient Advocates at QUEST are fantastic at removing obstacles so that the right person can participate in our trials.
What kind of expertise, research infrastructure and other resources are necessary to conduct AD research?
The essentials include:
- Medical professionals educated in AD diagnosis and progression (it is not just about memory!),
- Rooms appropriate for the memory assessments to be done,
- A nice place for the study partner to wait,
- Snacks on hand since the visits can take a long time,
- Caring staff to shepherd the participant through the trial.
At QUEST, our patients become part of the “QUEST Family” – we see the participants a lot and spend a lot of time with them. We find that people who enjoy the trial experience make successful trial participants.
Based on your experience, what are some considerations for clinical trial design to facilitate participation? AD trials have traditionally been associated with invasive procedures that introduce additional burdens on patients and their study partners. We love screening tools like the new blood test that assesses the probability of high amyloid burden (as part of eligibility criteria), compared with the prior invasive testing.
What future developments are you most excited about in AD research? There is still a lot to learn, and many trials in development are exploring different angles aside from beta-amyloid plaque. The current treatments help, but they are not the silver bullet to slowing or stopping disease progression. Growing evidence suggests there is more to AD disease progression than beta-amyloid plaque and therefore, more ways to treat or even prevent disease onset if you have an elevated risk of developing dementia.
