In the evolving landscape of the diagnosis and treatment of Alzheimer’s, updates and insights are regularly advancing. We’ve previously reported on the introduction and demise of the first breakthrough “treatment”- Aduhelm- and then on the introduction of Leqembi, the IV-administered antibody intended to slow down the pace of cognitive decline in those with mild cognitive impairment (MCI) or in the early stages of Alzheimer’s. Now, the FDA has approved another new medication produced by Eli Lilly called Kisunla (donanemab), which is intended to slow down the cognitive decline associated with MCI or early Alzheimer’s. Similar to Leqembi, Kisunla is intended to be administered by IV (once a month, as opposed to every 2 weeks for Leqembi). Also similar to Leqembi, the risks of the medication include brain swelling and bleeding, with a modest ability to slow down declines. Kisunla appears to be more expensive but unlike Leqembi, researchers anticipate that patients will be able to stop taking Kisunla once testing determines that the amyloid plaque associated with Alzheimer’s has disappeared. Experts differ on whether the benefits of the drug outweigh the potential harms, but the FDA was sufficiently convinced of the benefits to approve its use. The medication and monitoring for side effects will be covered by Medicare if the patient is enrolled in a program that keeps a data registry to track symptoms and side effects. For more on this new drug, click here.

While the introduction of another new treatment underscores the ongoing work and research to address the ravages of Alzheimer’s, the reality is that we still lack any therapies to prevent, stop, or reverse the damage that Alzheimer’s causes. Current medications can only slow down the progression of decline. And there continues to be ongoing debate about the direction and approach of efforts to combat Alzheimer’s. In recent weeks prominent articles have been published questioning the future of Alzheimer’s research and highlighting the disagreement about some of the basic premises about what causes Alzheimer’s. There is even disagreement among researchers and clinicians as to the actual definition of Alzheimer’s. As we’ve previously highlighted, current Alzheimer’s medications on the market are only valuable for those in the earliest stages of Alzheimer’s. Since we know that evidence of Alzheimer’s can appear in the brain years before symptoms surface, researchers are working to utilize blood test biomarkers to diagnose Alzheimer’s well before a patient experiences memory problems or other telltale signs, intending to someday prevent symptoms from ever occurring. Once symptoms appear, there has already been significant damage to the brain. However, diagnosing Alzheimer’s disease without the presence of clinical symptoms is currently controversial, and no one is advocating the testing of unimpaired individuals in the clinical setting at this time. While blood biomarkers herald a less invasive diagnostic tool than previous methods of diagnosing Alzheimer’s, it’s unclear at present what they mean practically for clinicians dealing with real patients right now. It’s also important to know that about 25% of those who have amyloid plaque in their brains, the hallmark of Alzheimer’s, do not have memory impairment. For more on the challenge of bridging the diagnostic gap between Alzheimer’s researchers and clinical reality, read here.

There is one additional new study addressing Alzheimer’s that also needs to be highlighted. Published in the journal Alzheimer’s Research and Therapy, this new trial examined the impact of intensive lifestyle changes on the progression of MCI or early Alzheimer’s. This randomized, controlled clinical trial, spearheaded by Dr. Dean Ornish, a pioneer in preventive cardiology and lifestyle medicine, resulted in improved cognition and functioning for patients undergoing intensive lifestyle changes as compared to the control group. The intervention group engaged in a largely plant-based diet, moderate aerobic exercise, stress management, and support groups to determine if these lifestyle changes alone (without medications) could improve functioning in patients with evidence of MCI or early Alzheimer’s.  While this was a small study and not everyone in the intervention group improved, it does suggest once again that lifestyle changes can potentially be an important part of addressing an Alzheimer’s diagnosis, even once symptoms appear. More evidence of that potential benefit comes from the experiences of Dr. Daniel Gibbs, a neurologist who has lived with an Alzheimer’s diagnosis for 8 years, and who was recently interviewed in JAMA Network. He is living proof that attention to lifestyle can keep many of the symptoms of Alzheimer’s at bay, and that such a diagnosis does not have to be the dreaded disaster that many imagine it must be. He has generously shared his wisdom and advice in several venues, including 2 books, A Tatoo On My Brain, and his recently published set of essays, Dispatches from the Land of Alzheimer’s. You can also watch a documentary about his life since his diagnosis here.