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
While deaths from COVID-19 have naturally been a major focus over the past 18 months, cardiovascular disease (CVD) remains a significant and growing problem. Even during the pandemic, heart disease was the leading cause of death in 2020. More than 868,000 Americans die of heart disease or stroke every year. That’s one-third of all deaths.
Nearly a quarter of men (23%) and 14% of women between ages 60 and 79 have some type of heart disease and millions more are at risk due to hypertension, high cholesterol, obesity, family history, or other risk factors.
The pandemic may have even worsened rates of CVD, as many people avoided or delayed routine health care and management of chronic conditions. For those over 80, the rate of CVD jumps to 36% for men and 21% for women. As the population of older adults in the U.S. increases to a projected 22% in 2050, heart disease will continue to impact mortality and morbidity rates. So it makes sense to become familiar with one of the leading types of heart disease, atherosclerosis. Continue reading
Falls are the leading cause of injury and death in older adults. Those with cognitive impairment are two to three times more likely to fall than those who are cognitively intact. We also know that certain medications can increase the risk of falls in older adults. According to researchers at Texas A&M University, those with dementia who regularly took pain medication and those with probable dementia who took pain medication two or more days a week in the prior month were more likely to fall compared to those without dementia, according to the researchers. Continue reading