Right now, roughly six million Americans are forgetting their lives as a result of Alzheimer’s— a devastating disease that progressively interferes with, and eventually destroys, cognitive function and memory— and unless we do something drastic about it, this number will more than double by 2050. That’s a tall order considering that both 2022 and 2023 were hailed as the “era of Alzheimer’s Disease treatments” and it’s likely that medical advancements for Alzheimer’s will continue strong well into 2024. As we learn more about the disease and dementia in general, the closer we come to putting an end to Alzheimer’s once and for all.
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What we know about Alzheimer’s dictates how we develop treatments
The exact cause of Alzheimer’s is unknown. However, scientists believe that its onset and progression are connected to changes in the brain. These changes include the buildup of reactive and toxic proteins— including beta-amyloid 42— around brain cells and neurons. In turn, this causes inflammation and damage that disrupts cellular and neural activity and ultimately results in decreased memory, cognitive function, and eventually the ability to carry out the simplest of tasks, like dialing a phone number.
Medical science has made significant strides in the development of advanced treatments over the past decade. However, the majority of FDA-approved treatments for Alzheimer’s focus on the management of symptoms or delayed progression of the disease. There are two categories of drugs approved by the FDA for the treatment of Alzheimer’s: drugs that treat the cognitive and non-cognitive symptoms of the disease, and drugs that change disease progression.
Treatments available to patients now are offering hope and some relief
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There are currently five FDA-approved drugs available for the treatment of the cognitive symptoms of Alzheimer’s Disease, like memory and thinking— donepezil, galantamine, rivastigmine, memantine, and memantine + donepezil— and two FDA-approved drugs for the treatment of non-cognitive symptoms— suvorexant for insomnia, and brexpiprazole for agitation.
Treatments specifically targeted at slowing the decline of cognitive function in patients with early Alzheimer’s have provided some hope in recent years. There are just two treatments currently approved for the change of progression in Alzheimer’s Disease, though there are also promising drug candidates in development right now. Just two years ago, in 2021, the FDA approved aducanumab, a breakthrough treatment for Alzheimer’s Disease that data shows can slow the progression of the disease in patients with early or mild Alzheimer’s, ultimately increasing and extending quality of life.
Lecanemab (Elsai and Biogen) received accelerated approval in January 2023 for its potential to slow cognitive decline in patients with early to moderate Alzheimer’s. Lecanemab also has shown no signs of being able to reverse the symptoms or provide long-term, sustained improvement, even after 18 months of treatment. Drug candidate donanemab (Eli Lilly and Company) is showing significant progress in stemming the progression of Alzheimer’s Disease from one stage to the next in clinical trials. Though all of these treatments come with side effects, this rapid progress in the treatment of Alzheimer’s Disease is helping patients right now while researchers continue to improve on these and other treatments.
The future of Alzheimer’s Disease diagnosis and treatment
There is currently no FDA-approved Alzheimer’s Disease treatment on the market that can reverse the symptoms and damage done by the disease. But that doesn’t mean it won’t ever happen. In fact, right now, researchers are working on new treatment candidates for Alzheimer’s Disease that are showing promising results.
Last year, a new treatment candidate made headlines when results from phase 2a clinical trials showed not only that the drug could improve cognition and function during the one-month double-blind study, but that it was happening in patients with moderate to severe Alzheimer’s. Importantly, those improvements happened with little to no side effects. The Open Label Extension (OLE) study that followed showed disease reversal in 47 percent and disease stabilization in 28 percent of participants, including those with severe Alzheimer’s Disease, after only three months of treatment. An upcoming phase 2b clinical trial will collect and analyze clinical data in moderate to severe Alzheimer’s patients over the course of a full year to further prove the efficacy, safety, and sustainability of the treatment. The outcome of the phase 2b clinical trials, paired with prior results, could help to put this new treatment on an accelerated pathway to distribution, a move that if it occurs, would mark the availability of the first drug with the potential to reverse the effects of Alzheimer’s Disease.
As exciting as this future is, there’s more work yet to be done. Patients typically have Alzheimer’s Disease long before they experience outward symptoms. Known as pre-clinical Alzheimer’s Disease, the effects of dementia can begin to occur 10 to 15 years before patients experience the types of symptoms that result in doctor’s visits and diagnosis. Diagnosis itself can also require many medical appointments over successive months, and treatment may not always begin right away. We need better diagnostics paired with earlier diagnosis and improved patient access and education. Empowering patients and their families to understand symptoms, family history, and what to do about it are critical in combatting the devastating effects of Alzheimer’s Disease. The best diagnostics in the world, paired with the best treatments, or even an eventual cure, won’t help if people don’t know when to talk to their medical provider.
A future without Alzheimer’s Disease could be just over the horizon. But we have to all work together to make it happen.
Photo: Andreus, Getty Images
Dr. Dongxu Sun is the founder and CEO of Truebinding Inc., where he is leading a team of multi-discipline scientists to develop monoclonal antibody drug candidates targeting novel pathogenic factors for AD and other indications. He has over seventy issued or pending patents covering those antibodies for treatment of neurodegenerative diseases and other indications.
