New drugs are here and why sex matters

By JAMES DOWD

The prescription drug donanemab, aimed at treating early-stage Alzheimer’s Disease, earned the unanimous backing of a medical advisory committee in June and is likely to secure approval by the Food and Drug Administration by the end of the year.

The decision was applauded by the Alzheimer’s Association.

In a statement on the organization’s website, president and CEO Joanne Pike said, “A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening. Now we need more types of treatments, targeting a variety of aspects of the disease, with greater efficacy and safety. This will lead to possibilities for combination therapies that address the complexity of the disease.”

Developed by Eli Lilly, donanemab has shown promise in clinical trials by slowing advancement of the disease in patients with mild cognitive impairment. If okayed by the FDA, donanemab will be the second Alzheimer’s drug in the last two years to win approval for use in the United States. In 2023, the FDA approved Leqembi, developed by Tokyo-based pharmaceutical company Eisai.

The approval of both drugs is an encouraging sign to Lee Stein, MD, of Neurology Clinic in Cordova.

Lee Stein, MD

“This is the third medication that’s been developed within the span of a few years and it’s on the verge of being approved for use,” Stein said. “Aduhelm was the first to be approved, but it was expensive and wasn’t as effective as hoped. However, the development of these two new drugs is exciting in the study of Alzheimer’s and offers great promise in the ways to treat it.”

The medications are not cures, Stein emphasized, but in clinical trials have been shown to slow the progression of dementia. There are potential side effects that some may be uncomfortable accepting, such as the chance of swelling in the brain or bleeding, but many are willing to accept the risk.

And with more patients being diagnosed with Alzheimer’s, the demand for these drugs is likely to increase.

“Alzheimer’s is one of the leading causes of death for adults in the United States, particularly among women,” Stein said. “About two-thirds of Alzheimer’s patients are women and not only are they getting it more, they’re living longer with it.”

One reason may be that because women live longer than men on average, their chances of getting Alzheimer’s are greater. Genetics and hormonal factors may also play a part, Stein said. Women also have a greater tendency toward autoimmune diseases, which could also contribute to their vulnerability to Alzheimer’s.

Genetic tests to gauge the risk of developing Alzheimer’s have been around for years, Stein said, but until recently there were few reasons to undergo such testing. The development of Leqembi and donanemab has changed the landscape.

“Before these drugs were available, there was really nothing you could do about it so many patients weren’t motivated to get tested when they began showing symptoms of early cognitive decline,” Stein said. “The likelihood is that patients who are in more severe decline will probably not respond as well to these medications because all of these studies were for those in early disease, but for those who are good candidates, the medications could offer better quality of life.”

Although the pharmaceutical breakthroughs do not promise a cure for Alzheimer’s, Stein is optimistic that one day the disease will at least be controllable. Like other once-life-threatening diseases that have been eradicated or greatly diminished, Stein hopes Alzheimer’s will be added to that list.

Until then, older adults should engage in lifestyle practices that promote mental and physical health. At the top of the list, Stein said, is adequate sleep. Most mature adults need seven to eight hours of sleep for healthy brain functioning. Physical activity is another must-do, along with observing a healthy diet, keeping well hydrated and decreasing vascular risks associated with high cholesterol, diabetes, hypertension, and smoking.

And for those who may feel guilty about time spent on gaming apps such as Wordle and Connections, Stein has some good news.

“Cognitive exercises that keep the brain sharp such as crossword puzzles or apps with word games or memory exercises are all great and I recommend them as engaging ways to stimulate the brain,” Stein said. “We’re not where I wish we were with this disease, but we’re moving forward and it’s a very exciting time in the field and because of research and development we’re finally able to provide treatment that appears to slow the disease. I believe that gives us all a bit of hope for the future.”