Progress on Alzheimer’s disease has been slow and, at times, disappointing over the past decade.
Scientists are still trying to understand the exact mechanisms behind the progression of Alzheimer’s disease in the brain.
Researchers are also struggling to develop a drug that can treat it. So far, the best they have found are drugs that temporarily slow the progression of the deadly disease.
In the summer of 2021, the Food and Drug Administration (FDA) approved the use of Adulhelm, the first new drug approved for the treatment of Alzheimer’s disease in 18 years.
However, the approval came despite objections from some members of an advisory committee who felt the drug had not been fully shown to be effective.
A few weeks later, the FDA updated its guidelines for Aduhelm, recommending it only for people in the early stages of Alzheimer’s disease.
There was more disappointment earlier this month when it was reported that the drug crenezumab had not worked well in phase 3 clinical trials.
There’s at least one other potential treatment for Alzheimer’s disease before the FDA now.
It’s lecanemab, a monoclonal antibody designed to slow the progression of Alzheimer’s disease. The drug was granted Breakthrough Therapy designation by the FDA in June 2021. It was granted fast-track designation in December 2021.
On the diagnostic front, researchers this weekend unveiled details of an MRI-based brain scan that can potentially diagnose Alzheimer’s disease before symptoms appear.
How significant are these potential new advances and do they offer reason for optimism?
Healthline spoke with Rebecca M. Edelmayer, Ph.D., senior director of science engagement for the Alzheimer’s Association for some perspective.
Health Line: What are the upcoming developments we should be looking for in terms of Alzheimer’s diagnosis?
Edelmayer: “The field of Alzheimer’s disease research is excited about the advances we have made in the diagnosis of Alzheimer’s disease over the past decade, particularly with the development of biofluid testing technologies capable of detect the hallmarks of Alzheimer’s disease.
We now have FDA-approved brain imaging technologies that can visualize hallmark changes, such as the buildup of amyloid-beta plaques and tau tangles associated with Alzheimer’s disease.
However, there is an urgent need for simple, inexpensive, non-invasive, and readily available diagnostic tools for Alzheimer’s disease, such as a blood test.
In addition to improving diagnosis, new testing technologies could potentially support drug development for Alzheimer’s disease in several ways. For example, helping identify the right people for clinical trials and tracking the impact of tested therapies.
Currently, research developing new blood test technologies is making encouraging progress, but we do not yet know how long it will be before these tests are available for wider clinical use. Testing them in long-term, large-scale studies and in various populations is the next step, and some of these studies are already underway.
Health Line: How promising is new research on MRI-based brain scans for detecting signs of Alzheimer’s disease?
Edelmayer: “This new research approach uses machine learning and MRI scans to try to identify biological changes in the brain early in the Alzheimer’s disease continuum. That being said, this research is in its early stages and not ready to be used as a standalone diagnostic tool. This is a model that will need further testing in a larger set of data collected prospectively from a diverse group of individuals.
The model is developed using samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI), which is currently not a diverse representation of people living with or at risk of developing Alzheimer’s disease and other dementias. For the model to be effective in predicting Alzheimer’s disease and other dementias, it will need to be generalizable to the entire population with Alzheimer’s.
As noted by the authors, another important limitation is that the diagnostic model was developed for a type of MRI device using a particular magnetic field strength. With a variety of MRI scanners in use today, the results of this study are not generalizable to all types of scanners used to aid in diagnosis today.
All this to say that this research addresses an important issue in Alzheimer’s disease: early detection. With the FDA’s fast-tracking approval of the first anti-amyloid treatment for Alzheimer’s disease and more to come, it is critical that people with Alzheimer’s disease are diagnosed early in the disease process when treatment may be most beneficial.
“In addition, early detection of Alzheimer’s disease gives individuals and their families more time to plan for the future, participate in clinical trials, and seek out community resources.”
Health Line: Are you optimistic that significantly better diagnostic tools for Alzheimer’s disease will be available within the next decade?
Edelmayer: “Absolutely. Whether it’s scans that detect Alzheimer’s disease in the brain or fluid tests that detect markers of Alzheimer’s disease in the blood, we are accelerating faster than ever toward ways more accurate and accessible to diagnose Alzheimer’s disease.
With these technologies, the possibility of early detection and being able to intervene with treatment before significant brain damage from Alzheimer’s disease is a game-changer for individuals, families and our healthcare system.
A well-tested and verified blood test, for example, will make it possible to interpret and understand the progression of Alzheimer’s disease in much larger, more diverse and more robust populations.
Health Line: What are the upcoming developments we should be looking for in terms of Alzheimer’s treatment?
Edelmayer: “We are in a new phase in the treatment of Alzheimer’s disease. The Alzheimer’s drug pipeline is heating up. In the second half of 2021, there was renewed enthusiasm for the class of experimental Alzheimer’s drugs that target beta-amyloid.
These include drugs from Eli Lilly (donanemab), Eisai (lecanemab), and Roche (gantenerumab), all of which received breakthrough designation from the FDA in 2021.
Additionally, a wide range of strategies targeting neuroinflammation, protecting brain cells, and reducing vascular contributions to dementia – all funded by the Part the Cloud program – have been tested in clinical trials.
We expect the FDA to intervene on more therapies aimed at slowing, stopping, or altering the trajectory of Alzheimer’s disease in the fall of this year. »
Health Line: How much of a setback was the recent clinical trial of the drug crenezumab?
Edelmayer: “These initial results are disappointing. At the same time, we remain firmly optimistic based on the strong and diverse Alzheimer’s drug development pipeline, including potential new treatments in Phase 3 studies and, indeed, in all phases of the clinical tests.
We look forward to hearing more details about this clinical trial at the Alzheimer’s Association International Conference in San Diego on August 2, where the scientists will present a much more in-depth report of their findings.
Health Line: Do you hope that the new drug lecanemab awaiting FDA approval can be effective?
Edelmayer: “Based on the Phase 2 data, Eisai has 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 which is expected in fourth quarter of 2022.
We trust the FDA’s rigorous process when reviewing Phase 2 trial data, and we look forward to seeing Phase 3 data this fall.
Health Line: Are you optimistic about the possibility of having significantly better treatments for Alzheimer’s disease within the next decade?
Edelmayer: “This is an exciting time in Alzheimer’s disease research with more potential treatments – and more types of treatments – being investigated than ever before.
The FDA’s first accelerated approval of a treatment for Alzheimer’s disease has created a new level of interest and investment where we are now seeing more treatments being accelerated through the drug pipeline.
We know that Alzheimer’s disease 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 drug and non-drug strategies – is essential to realizing the association’s vision. of a world without Alzheimer’s disease and other dementias. ”