Progress on Alzheimer’s disease has been slow and, at times, disappointing in the past decade.
Scientists are still trying to figure out the exact mechanics of how Alzheimer’s progresses in the brain.
Researchers are also struggling to develop a drug that can treat it. So far, the best they’ve come up with are medications that temporarily slow the advancement of the deadly disease.
In summer 2021, the Food and Drug Administration (FDA) approved the use of Adulhelm, the first new medication authorized for Alzheimer’s treatment in 18 years.
However, the approval came despite objections from some members of an advisory panel who felt the medication had not been fully shown to be effective.
A few weeks later, the FDA updated its guidance for Aduhelm, recommending it only for people in the early stages of Alzheimer’s.
There was more disappointment earlier this month when it was reported that the drug crenezumab did not perform well in phase 3 clinical trials.
There is at least one other potential Alzheimer’s treatment before the FDA now.
It’s lecanemab, a monoclonal antibody designed to slow down the progression of Alzheimer’s. The drug was given a breakthrough therapy designation by the FDA in June 2021. It was granted fast track designation in December 2021.
On the diagnostic front, researchers unveiled details this weekend on an MRI-based brain scan that can potentially diagnose Alzheimer’s before symptoms appear.
How important are these potential new advancements and do they offer reasons for optimism?
Healthline spoke to Rebecca M. Edelmayer, Ph.D., the senior director of scientific engagement for the Alzheimer’s Association for some perspective.
Healthline: What are the upcoming developments we should be looking for in terms of Alzheimer’s diagnosis?
Edelmayer: “The Alzheimer’s research field is excited about the progress we’ve made in Alzheimer’s diagnosis in the last decade, especially with the development of biofluid testing technologies that can detect hallmarks of Alzheimer’s.
We now have FDA-approved brain imaging technologies that can visualize hallmark changes, such as the build-up of amyloid-beta plaques and tau tangles associated with Alzheimer’s.
However, there is an urgent need for simple, inexpensive, noninvasive, and easily available diagnostic tools for Alzheimer’s, such as a blood test.
In addition to improving diagnosis, new testing technologies could potentially support Alzheimer’s drug development in many ways. For example, by helping identify the right people for clinical trials and by tracking the impact of therapies being tested.
Right now, research developing new blood-testing technologies is making encouraging progress, but we do not yet know how long it will be until these tests are available for broader clinical use. Testing them in long-term, large-scale studies and in diverse populations is the next step, and some of these studies are already happening.”
Healthline: How promising is the new research on MRI-based brain scans being able to detect signs of Alzheimer’s?
Edelmayer: “This new research approach is using machine learning and MRI scans in an attempt to identify biological brain changes early in the Alzheimer’s disease continuum. That being said, this research is in its early days and it is not ready to be used as a stand-alone diagnostic tool. It is a model that will need more testing in a larger prospectively collected set of data from a diverse group of individuals.
The model is developed using samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI), which is not currently a diverse representation of those living with or at risk for developing Alzheimer’s disease and other dementia. For the model to be effective at predicting Alzheimer’s and other dementia, it will need to be generalizable to the broader Alzheimer’s population.
As noted by the authors, another significant limitation is that the diagnostic model was developed for a type of MRI machine using a particular strength of magnetic field. With a variety of MRI machines being used today, the results from this study are not generalizable to all types of scanners being used to aid in diagnosis today.
All this to say, this research is addressing an important issue in Alzheimer’s disease: early detection. With FDA accelerated approval of the first anti-amyloid Alzheimer’s treatment and more coming down the pipeline, it is vital that individuals with Alzheimer’s be diagnosed early in the disease process when treatment may be most beneficial.
“Plus, early detection of Alzheimer’s allows individuals and their families more time to plan for the future, participate in clinical trials and seek community resources.”
Healthline: Are you optimistic we can have significantly better diagnostic tools for Alzheimer’s within the next decade?
Edelmayer: “Absolutely. Whether it be scans that detect Alzheimer’s pathology in the brain or fluid tests that detect Alzheimer’s markers in the blood, we are accelerating faster than ever toward more accurate and accessible ways to diagnose Alzheimer’s.
With these technologies, the possibility of early detection and being able to intervene with a treatment before significant damage to the brain from Alzheimer’s disease would be game-changing for individuals, families, and our healthcare system.
A well-tested and verified blood test, for example, will enable interpretation and understanding of Alzheimer’s progression in much larger, more diverse and more robust populations.”
Healthline: What are the upcoming developments we should be looking for in terms of Alzheimer’s treatment?
Edelmayer: “We’re in a new phase of Alzheimer’s treatment. The Alzheimer’s drug pipeline is heating up. In the second half of 2021, there was renewed excitement in the class of experimental Alzheimer’s drugs that target beta-amyloids.
These include drugs from Eli Lilly (donanemab), Eisai (lecanemab) and Roche (gantenerumab), all of which received breakthrough designation by the FDA in 2021.
Plus, a diverse array of strategies targeting neuroinflammation, protecting brain cells, and reducing vascular contributions to dementia – all funded by the Part the Cloud program – advanced into clinical trials.
We expect FDA action on more therapies that aim to slow, stop or change the trajectory of Alzheimer’s disease in the fall of this year.”
Healthline: How big of a setback was the recent clinical trial for the drug crenezumab?
Edelmayer: “These topline results are disappointing. At the same time, we remain steadfastly hopeful based on the robust and diverse Alzheimer’s drug development pipeline, including new potential treatments in phase 3 studies and, in fact, in all phases of clinical trials.
We look forward to hearing more details from this clinical trial at the Alzheimer’s Association International Conference in San Diego on August 2, where the scientists will give a substantially more in-depth report of their findings.”
Healthline: Are you hopeful the new drug lecanemab that is awaiting FDA approval can be effective?
Edelmayer: “Based on the phase 2 data, Eisai completed an accelerated approval application for lecanemab for FDA review, which will be followed by a traditional FDA application based on their phase 3 data that are anticipated in Q4 2022.
We trust the FDA’s rigorous process as they review the data from the phase 2 trial, and we’re looking forward to seeing the phase 3 data this fall.”
Healthline: Are you optimistic we can have significantly better treatments for Alzheimer’s within the next decade?
Edelmayer: “This is an exciting time in Alzheimer’s research with more potential treatments – and more types of treatments – being investigated than ever before.
The first FDA accelerated approval of a treatment for Alzheimer’s has created a new level of interest and investment where we are now seeing more treatments accelerating through the drug pipeline.
We know that Alzheimer’s is a complex disease and we envision a future where effective treatment includes a powerful combination of therapies that address the disease in multiple ways.
Encouraging and supporting a diverse treatment pipeline, as the Alzheimer’s Association does through its Part The Cloud funding and other initiatives – including both drug and non-drug strategies – is essential to achieving the association’s vision of a world without Alzheimer’s disease and all other dementia.”