Robust Alzheimer’s Clinical Trial Portfolio Provides More Opportunities for Patient Participation
This is an exciting time for Alzheimer’s research. The first Alzheimer’s disease modifying drug, aducanumab (Aduhelm™), was approved by the FDA earlier this month. We understand more than ever about the biology of aging and the many processes in the body that go awry and contribute to Alzheimer’s in our aging population. And we have powerful new tools — biomarkers that help us diagnose Alzheimer’s earlier and match people to the right clinical trials. Many more biomarkers are on the way, with significant investment from the ADDF Diagnostics Accelerator.
Each one of these advances, and every new one on the horizon, is only possible because of the tens of thousands of patients who have participated in clinical trials. One of those patients is Phil Gutis, a friend of the ADDF who shares his thoughts about the importance of participating in clinical trials. Watch as Phil takes us through one of his infusion days as part of the aducanumab trial.
Alzheimer’s research has come a long way, but as Phil notes in the video, “Aducanumab is not a cure. It is a building block,” and the first in what we hope will be many new drug approvals. With an accelerating ability to implement rigorous clinical trials, we are now in the modern era of clinical trials for Alzheimer’s disease with over 120 drugs being evaluated in human studies. The drugs work on a wide range of targets from misfolded proteins like amyloid and tau, to inflammation, genetic alterations, and vascular dysfunction. The goal is to combine drugs in individualized ways to address each Alzheimer’s patient’s unique needs.
The aducanumab clinical trials were also a very important building block in advancing our research enterprise itself; they were innovative in their use of biomarkers. The biomarker used in the aducanumab trials was the Amyvid™ PET scan, which measures brain amyloid levels and was developed with support from the ADDF. More trials every day are following this model and using amyloid and other biomarkers to enroll and track patient progress.
And this brings us back to patients. There are many research opportunities available to patients and clinical trials can only happen with their participation. Each trial needs to enroll patients who are most likely to benefit from the specific drug being tested. But as Phil says in his video, “The biggest hurdle that the community has right now is the lack of enough people willing to participate in clinical trials.”
In addition to needing “enough” patients, it is also important that clinical trials include a diversity of patients reflecting the U.S. population. This will help researchers understand how treatment responses differ by age, race, ethnicity, and a host of other unique patient factors. I encourage patients and families to consider clinical trials, when possible. A great place to start for more information is the “Enrolling in Clinical Trials” section of the ADDF Patient & Family Resources page.