MedCity Influencers, BioPharma

A New Alzheimer’s Drug is Finally Here – Our Healthcare System is Far from Ready

The new year always brings hope, but this January that hope was palpable for the over 50 million people with Alzheimer’s Disease (AD) worldwide, their families, friends, and clinicians when the Food and Drug Administration (FDA) granted accelerated approval for Leqembi to treat mild cognitive impairment or dementia due to AD. For the first time, […]

The new year always brings hope, but this January that hope was palpable for the over 50 million people with Alzheimer’s Disease (AD) worldwide, their families, friends, and clinicians when the Food and Drug Administration (FDA) granted accelerated approval for Leqembi to treat mild cognitive impairment or dementia due to AD. For the first time, a therapy will be available to slow the otherwise relentless progress of AD. Compared with prior medications in the same class, the clinical trial results that led to the FDA’s approval of Leqembi reveal significant, clinically demonstrable benefits – slowing disease progression by about 30%.

While it is unclear how impactful Leqembi may be for each individual and the benefits will need to be balanced against risks and costs, these findings mark a true inflection point in the battle against AD. They also underscore the need to implement a long overdue transformation of our healthcare system and evolve clinical practices to ensure early detection and empower individuals to make timely intervention choices; time is of the essence with the FDA’s full approval decision date set for July 6th.

Our current approach to Alzheimer’s and other dementias is largely reactive: routine screening is rare, and evaluation occurs only when patients or families raise concerns. Furthermore, evaluations are largely reliant on specialists with limited availability – even in places with the highest supply of them. This means that dementia diagnoses happen on average over a decade too late, and that treatment simply promotes years of disability rather than preservation of function and quality of life.

Borrowing lessons from car racing, I propose a pit stop model for brain care to win the brain health race, meaningfully address the threat of dementia, and help people benefit from scientific advances in a timely and most effective manner.

Scheduled pit stops were introduced at the 1963 Daytona 500 by the Wood Brothers Racing team. Before then, drivers pushed their cars to the brink, hoping they would not break down. When one did, a team of mechanics ran to retrieve it, towed it to the pit lane for repairs, and hastily returned it to the track. Unfortunately, often too much time was lost, or damage was beyond repair. When the Wood Brothers introduced scheduled pit stops, they won the race and transformed car racing for good. It is time to make a similar transformation in brain care and draw the full benefit from Leqembi and other medications expected over the next few years.

Brain care pit stops can start as regularly scheduled checks to screen for cognitive problems, taking into consideration each person’s age, gender, race, health, and circumstances. To make this happen and capitalize on the potential of new treatments, we must:

  1. Expand public education: Memory and cognitive loss is not part of “normal” aging but an indication of brain pathology or dysfunction; people who experience or worry about cognitive decline should seek an evaluation, and primary care providers (PCPs) should conduct regularly scheduled cognitive screens on all their patients after a certain age.
  2. Put PCPs in charge: PCPs should oversee the pit stop model of brain care. The rising shortage of neurologists and other relevant dementia specialists causes wait times of six to 12 months in most developed countries, disproportionately affecting vulnerable populations. This wastes valuable time for interventions like Leqembi, which have the biggest impact at early stages, before patients show noticeable signs.
  3. Embracing digital cognitive tests: PCPs need efficient and reliable cognitive testing tools that integrate into their time-pressured workflows. Digital assessment technologies can uncover issues not detectable using standard paper-based tests in individuals who are otherwise clinically unimpaired and thus enrich specialist referrals for earlier possible evaluation and treatment initiation.
  4. Rethinking diagnosis methods: Newer technologies can also help clinicians determine if AD is the cause of the dementia, which is crucial for therapies like Leqembi. This presently happens through expensive positron emission tomography (PET) scans or lumbar punctures (LPs) to assess levels of amyloid and tau proteins. Often though, even when an expert suspects AD, results are negative. AI-enabled digital cognitive tests are more sensitive than clinical impressions and can help reduce the occurrence and costs of negative PET scans or LPs. In the future, a short digital test could be paired with appropriate blood tests to check if a patient has both functional impairment and biological markers indicative of AD, with more elaborate tests used for confirmation purposes.
  5. Avoid “silver bullet” thinking: For most individuals with AD, Leqembi and future treatments will likely be most valuable as part of a multi-intervention strategy, including addressing co-morbidities and lifestyle modifications. Indeed, strong scientific evidence demonstrates that addressing modifiable risk factors early can fend off or delay up to 40% of dementia cases. Combination therapy trials are being designed as we speak, and the AD field should aim to replicate successes in oncology or cardiovascular disease.

Since their introduction in 1963, pit stops have changed the car racing game and continued to evolve; the brain care pit stop model can similarly revolutionize brain health at this pivotal moment. By using the latest practices and technology, we can evolve to monitor patients longitudinally, inform when and why to ‘pit stop’ for a PCP visit, and indicate when to engage a specialist. This will improve the care of patients with dementia and enable health systems to translate scientific advances – like the approval of Leqembi – rapidly and smoothly for the benefit of all. As a first step, we must focus on quickly implementing brain care pit stops as an efficient and effective primary care workflow to empower individuals to minimize their risk of cognitive decline, detect problems early, and adopt interventions to address them.

Photo: Andreus, Getty Images

Editor’s Note: The author has confirmed that he has no financial relationship with Eisai, the Japanese company that makes Leqembi. Nor was he involved in clinical trials of the drug.

Alvaro Pascual-Leone, MD, PhD, is co-founder and Chief Medical Officer of Linus Health. He is also a Professor of Neurology at Harvard Medical School, a Senior Scientist at the Hinda and Arthur Marcus Institute for Aging Research, and the Medical Director of the Deanna and Sidney Wolk Center for Memory Health at Hebrew SeniorLife (HSL) in Boston, MA. A major focus of Alvaro’s scientific work is to characterize and promote brain health across the lifespan, prevent age-related cognitive decline, and minimize disability in patients with neuropsychiatric disorders while gaining fundamental insights into human brain function. He is considered a pioneer in non-invasive brain stimulation and has published more than 800 scientific peer-reviewed papers. Alvaro remains a practicing cognitive neurologist and dementia specialist with a focus on comprehensive, patient-centered, personalized care. He obtained an MD and PhD in Neurophysiology at the University of Freiburg i.Br., Germany. He completed his residency in Neurology and a fellowship in Clinical Neurophysiology at the University of Minnesota. Alvaro trained in Human Cortical Neurophysiology and Motor Control at the National Institutes of Health and was a Scientist at the Spanish Research Council’s Cajal Institute. Alvaro has been honored with many international awards and is an elected member of the Spanish Royal Academy of Pharmacy.

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