Demystifying clinical trials was the topic of our March Alzheimer’s Talk—how they work, what you need to know and why they’re important. UsAgainstAlzheimer’s Board Member and Author/Caregiver Advocate Meryl Comer moderated an insightful discussion with:
- Reisa Sperling, MD, Harvard neurology professor and project leader of the NIH-funded A4 Study, a first-of-its kind prevention trial in older adults with evidence of early Alzheimer’s but no symptoms
- Geri Taylor, who is living with early-stage Alzheimer’s and participating in a clinical trial, and Jim Taylor, her husband and care partner—both were profiled in a 2016 New York Times article
- Nate O’Keefe, Founder and CEO of Roobrik, which worked with UsAgainstAlzheimer’s to develop a decision tool, Is Clinical Research Right for Us?
Should You Join a Clinical Trial?
As Nate observes, “Almost no one is innately equipped to make an informed decision about this.” You may not be aware of all of the clinical trial options; you may be uncertain about whether changes you’ve noticed are serious, or inertia may keep you from taking the first step. A decision tool, like Roobrik’s, can help. It walks you through questions that can help you understand what kinds of studies might be a good fit for you. Nate says, “Whether you’re the ‘worried well’ or recently diagnosed with Alzheimer’s, this process can empower you to take action. Even taking this small step is an act of heroism.” The decision tool report can help guide a discussion with your doctor and family about clinical trials.
Finding the Right Study
Geri had used TrialMatch to look for studies. Then Jim saw a news article about a Biogen study that seemed just what she wanted – an FDA-approved, double-blind interventional trial. While that meant she might get a placebo instead of an experimental drug, as Jim says, “If you don’t join a clinical trial, you’re on the placebo the rest of your life.”
Dr. Sperling notes that Alzheimer’s clinical trials are getting longer because scientists are trying to intervene earlier, so they follow patients for longer timeframes. To gather such long-term data, researchers try to make it easy to stay enrolled for years—offering more satellite locations, for instance.
Not all studies mean taking an experimental drug. Online studies, phone studies, caregiver studies and others all may help find treatments or better support for families.
Another resource is Antidote’s clinical trial search tool.
Advantages of Being in a Clinical Trial
Jim says the advantages are many: learning more about Alzheimer’s, replacing fear with knowledge, which can lead to better decisions; receiving the very best medical care, since an expert study team follows your health closely; no costs to you (you may even receive a small stipend); an Alzheimer’s research team that knows better than anyone what you’re going through and can answer your questions; and the psychological advantage, the mood boost, of taking action to help find a cure.
Fears & Obstacles
- I don’t want to know: Most Alzheimer’s trials require that you learn your genetic risk or amyloid status. (The DIAN Study does not.) Dr. Sperling sees knowledge as power: “People are scared to know because they think there’s nothing they can do. Clinical trials are a way that you can be proactive—hopefully to help find a successful treatment for you and others in your family. Many are willing to learn their status if they can do something positive with that knowledge.”
- I live far from research centers: TrialMatch sorts by distance. Look for telephone or online studies via ClinicalTrials.gov. Find studies funded or run by the National Institute on Aging at NIH. Search for options through Cleveland Clinic’s Healthy Brains or the Memory Strings Community. Participate in online research: join UsAgainstAlzheimer’s A-LIST.
Will I Qualify?
- Family history: A close relative with Alzheimer’s is unfortunately a strong predictor for the disease. If you have family history but no symptoms, Dr. Sperling suggests a prevention study like the EARLY Trial or the Generation Studies.
- No diagnosis or family history: Dr. Sperling say you can still be of value to a clinical trial. As trials look at earlier stages of Alzheimer’s, more will seek healthy people in their 60s or 70s. Consider signing up for the Alzheimer’s Prevention Trials Webstudy, Alzheimer’s Prevention Registry or Brain Health Registry.
Study Partner’s Role
An Alzheimer’s trial may require participation by a care partner. At some of Geri’s appointments, for instance, Jim shares observations of her cognitive status and functional abilities with the research team.
Knowing Why You Want to Join a Study
Nate emphasizes knowing why you want to join a study: “If you don’t acknowledge the ‘why,’ you may have trouble with smaller decisions along the way.” Motivations include the chance of a treatment/cure for you or a loved one, the hope of preventing disease, honoring a road traveled with a family member, or helping the world generally. Geri finds being in a trial empowering. Alzheimer’s also struck four of her family members, so she says, “For my family, myself and others, I want to be in this fight.”
Hear more questions from listeners and answers from our panelists. Listen to the full conversation below -- or follow Alzheimer's Talks through iTunes Podcasts.