Cases of Alzheimer’s disease are rising throughout the world and could triple by 2050, according to a recent analysis in The Lancet. While much of this increase can be traced back to the fact that we’re living longer, researchers also concluded that three key modifiable risk factors — smoking, high body mass index and diabetes — also contribute to the increased burden and could cost health systems around the world billions in long-term services and supports.
The number of people with Alzheimer’s disease is also increasing in the U.S. and other high-income nations thanks to increased life expectancy. By 2050, cases of Alzheimer’s in those 65 and older could top 12.7 million in the U.S. alone. The rate, however, will actually decline slightly, because of the sheer size of this demographic. And can be explained largely by educational changes, according to Eileen Crimmins, Ph.D., chair in gerontology at the USC Leonard School of Gerontology.
As the search for treatment and a cure for the disease continues, addressing risk factors is one of our only viable tools. Journalists who are following this issue have an opportunity to report on other potentially fruitful research you may have missed, as well as look at how health systems in the U.S. and around the world are planning to address this looming crisis. There are also new opportunities to look into COVID-19’s effects on the brain and whether we will see more cases of dementia in the future. We also recently reported on continuing disparities in care among Blacks, Hispanics, Asian Americans and Native Americans, who continue to have a higher burden of illness and lower access to care compared with whites.
This is part 2 of a package on sponsored disease awareness campaigns and other controversial drug marketing practices, focusing on Biogen’s efforts to build a market for its recently approved drug for Alzheimer’s disease. Check out part 1, which posted on August 4.
Biogen’s marketing campaigns about mild cognitive impairment drew protests from several physicians, but don’t expect federal regulators to more strictly regulate such ads and similar disease-awareness promotions.
Neither the FDA nor the FTC actively monitors claims made in pharmaceutical marketing about medical conditions if the name of a medicine isn’t mentioned. Continue reading
New marketing campaigns about forgetfulness and distraction could lead people to seek the costly Aduhelm drug for Alzheimer’s disease even if they haven’t been diagnosed with the condition, several experts have warned.
By working to expand the market of people seeking treatment for mild cognitive impairment, Biogen could needlessly expose many people to a drug with known risk but as yet unproven potential benefit, some researchers said. (See “Do we all have Alzheimer’s? Drug makers might want you to think so,” Adriane Fugh-Berman and Patricia Bencivenga of Georgetown University, Baltimore Sun, July 16, and “‘When Memory Fades’: Misinformation about Alzheimer’s disease and Aduhelm must be limited,” Madhav Thambisetty of Johns Hopkins University, STAT, July 21.) Continue reading
Editor’s Note: This is part 2 of a two-part package on the pipeline for Alzheimer’s disease drugs. Check out part 1.
While the controversy surrounding the FDA’s approval of Biogen’s adumanucab for Alzheimer’s disease continues, several other drug companies are developing their own therapies to prevent or slow the progression of the disease.
One of those new drugs, ALZ-801, began National Institute of Aging-funded Phase 3 trials on June 4. Unlike aducanumab or other drug candidates from Eisai, Eli Lilly and Roche, which attack amyloid plaque after it forms in the brain, biotech startup Alzheon, Inc. aims to help people with AD who have two copies of the ε4 allele of the apolipoprotein E gene (APOE4/4), a known risk factor for Alzheimer’s disease. The goal is to prevent plaque from forming in the first place or prevent additional plaque from forming in those who already show clinical symptoms of Alzheimer’s. ALZ-801 is also the only drug currently under investigation administered orally and which uses precision medicine strategy (factoring in individual genetics and lifestyle), according to the company. Continue reading
Eli Lilly recently announced that the FDA had granted a breakthrough therapy designation for donanemab, its investigational antibody therapy for Alzheimer’s disease. The designation means the FDA will expedite the drug’s development and review because it treats a serious condition, and early evidence has shown enough improvement on key clinical measures compared to other drugs on the market. This should mean it has a good chance of being effective in treating the condition.
Donanemab, also called N3pG, is an investigational antibody that targets a modified form of beta-amyloid, aiming to clear out plaques that have built up in the brain. Lilly’s Phase 2 trial, TRAILBLAZER-ALZ, studied the efficacy and safety of donanemab in patients with early, symptomatic Alzheimer’s. The results, which appeared in the May 6 New England Journal of Medicine, concluded that “donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed.” Continue reading