With no effective prevention or long-term treatment, receiving a diagnosis of Alzheimer’s disease can seem like a fate worse than death for patients and their families and caregivers. However, a wave of innovation is bringing new hope to the 7 million Americans already living with Alzheimer’s disease and the 500,000 who will receive this devastating diagnosis each year.
The urgency to bring new treatment options to market is escalating in tandem with the disease’s prevalence as the nation’s 65-plus population—the group most at risk for Alzheimer’s—grows.
Sobering Alzheimer’s Realities
According to the Alzheimer’s Association’s 2024 Alzheimer’s Disease Facts and Figures, nearly 11% of the total U.S. population has been diagnosed with Alzheimer’s dementia. While this figure includes about 200,000 Americans with younger-onset dementia, prevalence is highest among those aged 65 and older. The vast majority (75%) are those aged 75 and older.
The Alzheimer’s Association report cites multiple studies suggesting Alzheimer’s and other dementias are substantially underdiagnosed, especially in the early stages when symptoms are mild. This underdiagnosis is particularly prevalent among older Black and Hispanic adults. Mild cognitive impairment (MCI), a precursor to Alzheimer’s and other dementias, is missed or misdiagnosed at even higher rates, with one study estimating that just 8% of older Americans living with MCI are diagnosed.
Many who have been diagnosed have not been told or are otherwise unaware of the diagnosis; about 50% of Medicare beneficiaries with a diagnosis of Alzheimer’s or another dementia in their Medicare billing records reported they were not told of the diagnosis.
Missed or delayed diagnoses can give rise to several potential harms, including treatment delays, limited care planning time, higher care costs, and negative impacts on the patient’s physical or mental health. Mental health impacts can also extend to family, loved ones, and potential caregivers. This trend is especially troublesome for those living with MCI, as this is the stage when treatment and planning are most effective.
A Dearth of Options
The state of Alzheimer’s treatment is as sobering as the disease’s statistics. There is no cure, and just two drugs have been approved by the Food and Drug Administration (FDA) to slow its progression: Donanemab (Kisunla™) and Lecanemab (Leqembi®). Both are intravenous infusion therapies approved to treat early Alzheimer’s disease, including people living with MCI or mild dementia with elevated levels of beta-amyloid in the brain.
Classified as monoclonal antibodies (MABs), these medications work by targeting and removing abnormally elevated toxic amyloid protein in the brain, a hallmark of Alzheimer’s disease. However, at best, they can temporarily slow the cognitive decline rate. They mask the cognitive symptoms of the disease but cannot modify it. They can also have troubling side effects such as Amyloid-Related Imaging Abnormalities (ARIA), including ARIA-E (edema or swelling in the brain) and ARIA-H (hemorrhage or small blood leaks in the brain).
While ARIA can occur naturally in Alzheimer’s disease, the risk is heightened by taking an MAB medication. It occurs in approximately 35% of people taking an MAB, most of whom will not experience any telltale symptoms of its onset. Thus, those taking MABs require careful monitoring, including regular MRI brain scans, to detect ARIA’s presence.
Alzheimer’s Moonshot Shakes Things Up
The good news is that there are new treatment options are on the horizon, thanks in large part to StartUp Health’s Alzheimer’s Moonshot Community, which was established in January 2024 with support from Gates Ventures and the Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostic Accelerator (DxA). The Moonshot Community seeks to accelerate innovation around Alzheimer’s disease and related dementias by carefully curating expertise and innovation from companies that span the full spectrum of Alzheimer’s care, from awareness and early detection to diagnosis, treatment, and support.
While new drugs tend to get the most attention, a quiet but powerful wave of innovation is underway within the Moonshot Community. Many in this community are focused on bringing safe, effective, and less expensive treatments to market, including noninvasive approaches using novel techniques like electrical stimulation, light therapy, and radio waves.
One community member is developing a unique ultrasound helmet to restore brain function, while another offers an app, classified as a Class I medical device, for behavioral activation to slow cognitive decline. Another is leveraging electrical brain stimulation to significantly slow Alzheimer’s disease progression, while a fourth is undertaking clinical trials to test the use of culture-expanded medicinal signaling cells (MSCs) sourced from the bone marrow of young, healthy adult donors to fight Alzheimer’s through cellular regeneration.
Several innovations leverage the body’s glymphatic system—the brain’s detox system—to flush toxic proteins from the brain. One community member is testing a hypothesis that spinal movements create pressure gradients that drive cerebrospinal fluid into the glymphatic system by channeling it through meningeal lymphatic vessels (the network of vessels that drain waste from the brain and spinal fluid into the lymph nodes) to improve the clearance of the amyloid protein and other toxins and metabolites from the body.
Another company is developing, clinically testing, and marketing Transcranial Electromagnetic Treatment leveraging Radio Frequencies (TEMT-RF) to prevent, treat, and reverse cognitive decline caused by aging or Alzheimer’s and other neurodegenerative diseases. The first product is a cap that uses radio frequencies, which initial clinical trials and observational evidence suggest halts and even reverses the cognitive decline associated with Alzheimer’s disease.
Designed to be comfortably worn to administer TEMT-RF during daily in-home treatment, the cap directly attacks the disease process with electromagnetic waves that separate multiple toxic protein oligomers—increasingly believed to be the root cause of Alzheimer’s disease—throughout the brain, including inside neurons. TEMT-RF also re-balances the immune system in both the brain and blood and increases energy production in brain cells.
Optimism on the Horizon
The addition of two FDA-approved medications to the treatment arsenal and a plethora of non-drug options in various stages of development and testing—including several that are close to market-ready—have given the Alzheimer’s community reason for optimism. The ability of organizations like StartUp Health’s Alzheimer’s Moonshot Community to facilitate collaboration between the top innovators across scientific disciplines and those dedicating the resources necessary to move the needle on Alzheimer’s research.
By breaking down siloes, fostering meaningful collaboration, and supporting entrepreneurial innovation, Moonshot and its participants will accelerate the journey toward unlocking the secrets to treatment and, one day, prevention and cure.
Editor’s Note: Chuck Papageorgiou is CEO of NeuroEM Therapeutics, a leading clinical-stage biotechnology research company focused on commercializing its proprietary Transcranial Electromagnetic Treatment leveraging Radio Frequencies (TEMT-RF) technologies against Alzheimer’s disease and cognitive decline.