Why new Alzheimer’s drugs rely on early diagnosis & screening

July 19 2023

Promising new drugs are coming to market — early detection efforts need to catch up

Earlier this month, the FDA granted full approval to lecanemab, branded as Leqembi, for early stage Alzheimer’s disease in the US (mild cognitive impairment and mild dementia stages). It’s the second in a category of approved medications that target the fundamental pathophysiology of Alzheimer’s disease. This means that it focuses on the underlying process of the disease, rather than only treating the symptoms. More specifically, Leqembi works with the body’s immune system to clear amyloid protein build up from patients’ brains.

Another promising drug in development for early Alzheimer’s, Eli Lilly’s donanemab, similarly targets existing amyloid plaques. Most recently, at the 2023 Alzheimer’s Association International Conference in July, Eli Lilly presented encouraging results from donanemab’s phase 3 trial. The company reported that donanemab “significantly slowed cognitive and functional decline for amyloid-positive early symptomatic Alzheimer's disease patients, lowering their risk of disease progression,” sharing that “nearly half of participants at earlier stage of disease on donanemab had no clinical progression at 1 year.” On top of that, “study participants at [the] earliest stage of disease had even greater benefit, with 60% slowing of decline compared to placebo.” Regulatory action is expected by the end of the year.

The recent news about both Leqembi and donanemab bring new hope for current and future Alzheimer’s patients and their families. However, both treatments are targeted at the early stages of the disease – time is of the essence to diagnose Alzheimer’s and ensure patients don’t miss the window to benefit from such drugs. Unless we advance our methods of detecting mild cognitive impairment and dementia, many patients could miss out on the chance to protect their brains and quality of life for longer.

Why regular cognitive and dementia tests are vital

With one drug already on the market, and another promising new one readying to submit to the FDA, there is finally some hope for new options to treat Alzheimer’s disease. That said, the process of detecting and diagnosing Alzheimer’s — with a focus on the mild cognitive impairment stage — needs to change quickly.

Today, most cognitive testing happens only in response to symptoms - meaning only once Alzheimer’s and other dementias have progressed enough that patients or their families have noticed an impact on the person’s cognition and decided to raise it to their providers. Coupled with the fact that many patients hold back on surfacing issues due to concerns over stigma or a lack of knowledge about symptoms, the result can be a significant delay to when the diagnostic process even begins. From there, in the status quo patients then need to wait to see a specialist for further testing. All the while, the clock is ticking and treatment has not begun.

With more regular screening for cognitive impairment as part of annual check-ups for adults as they age, early diagnosis would no longer rely on patients or families expressing concerns. Maximizing the intervention window — and options within it — requires this shift, so brain health can achieve the same progress other areas of healthcare have already seen from more proactive healthcare practices. However, outdated, often paper-based cognitive tests have made regular screening for mild cognitive impairment in primary care — the most likely place to find it early — cumbersome and impractical. Therefore, it’s far from standard practice.

New testing methods for new treatment opportunities

Enter digital cognitive assessments, which can provide rich cognitive insights in a fraction of the time that long-standing cognitive tests do, making it more feasible to have widespread testing in primary care. Not only are they quick and easy to use, but these more modern assessment tools can often be administered by Medical Assistants and other staff, reducing reliance on providers and therefore making screening even more practical.

Not all digital cognitive assessments can deliver the same richness of insight though. Basic cognitive function and dementia tests can miss subtle signs of mild cognitive impairment critical to facilitating detection at the earliest stages of Alzheimer’s. Similarly, paper-based and digital cognitive assessments that only look at a patient's test outputs (e.g., final drawings) can miss early signs essential to maximizing a patient’s chances of securing a diagnosis within limited treatment windows. Using AI to analyze both a patient’s final cognitive test output as well as how they approach the testing process helps provide more robust information about cognitive function and pick up on signs of cognitive dysfunction not yet visible to the human eye. To learn more about how how more modern cognitive tests can benefit your patients and practice, download our guide for PCPs.


Did you know that 6 in 10 older adults in a recent survey said they would contact a provider for information and/or testing after learning of a new drug being approved for Alzheimer's? Get more insights on what patients said about prevention, detection, and treatment, in our report based on a survey of 1,000 people in the US who are 65 or older.