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☆ Medicare will require data on patient use for approved Alzheimer's drugs
▼ + stars: | 2023-06-01 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +3 min

Leqembi received accelerated approval from the FDA in January, based on limited evidence suggesting it would slow cognitive decline in early Alzheimer's patients. A panel of FDA advisers will discuss whether Leqembi should receive traditional approval next week, and a decision could come by early July. Medicare, the government health plan for Americans 65 and over, currently pays for Leqembi only if patients are enrolled in a clinical trial. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices rather than drugs. To receive Medicare coverage, people will need to be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer's and have a qualified physician participating in a registry.

Persons: Biogen, Leqembi, Eisai, Eli Lilly, Co's, Eli Lilly's, Alzheimer's, Sue Peschin, Manas Mishra, Leroy D'souza, Bill Berkrot Organizations: U.S, Eisai Co, FDA, Medicare, Centers, Medicaid Services, CMS, Alzheimer’s Association, Alliance for Aging Research, Thomson Locations: Bengaluru

☆ Regular internet use may be linked to lower dementia risk in older adults, study says
▼ + stars: | 2023-05-03 | by ( Jen Christensen | ) edition.cnn.com time to read: +6 min

A study published Wednesday in the Journal of the American Geriatrics Society suggested that older people who regularly used the internet were less likely to develop dementia. Scientists still don’t know what causes dementia, so the new research can’t pinpoint the exact connection between internet usage and brain health. A 2020 study found an association between cognitively stimulating jobs and a lower risk of dementia, for example. Research also suggests that most older adults most frequently use the internet for basic tasks like email, news or online banking. And learning new skills may be protective against dementia, studies suggest.

Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."

The Alzheimer's Association and the pharmaceutical industry say the drug companies are not directly involved in the campaign. But the Alzheimer's Association says patients simply don't have the time to spare. The agency did not address the Alzheimer's Association campaign. Association members have met 30 times with staffers for the state's 20 members of Congress, Ryan Schiff, the chapter's public policy manager, said. Spokespeople for all three companies said they do not work with the Association on its campaign to expand Medicare coverage of the drugs.

The Food and Drug Administration on Friday approved an Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the illness. The FDA approved Leqembi for use in people with mild cognitive impairment or early Alzheimer’s disease. Most drugs approved by the FDA for Alzheimer’s are aimed at helping symptoms, not actually slowing the progression of the disease. Friday's announcement comes on the heels of a scathing congressional report released last week detailing the approval of a different Alzheimer’s drug, called Aduhelm. The Alzheimer's Association has said that based on the Eisai and Biogen phase 3 clinical trial results, the FDA should approve Leqembi for early-stage Alzheimer’s.

☆ A family shares Alzheimer's on social media
▼ + stars: | 2022-12-09 | by ( Madeline Holcombe | ) edition.cnn.com time to read: +6 min

Now, in what doctors say are the final stages of her Alzheimer’s disease, Betty Pettit has found new ways to share the love on TikTok. Alzheimer’s disease is a progressive condition involving parts of the brain that control thought, memory, and language, according to the US Centers for Disease Control and Prevention. “It was just such a beautiful, pure moment,” Josh Pettit said. Despite its prevalence, Josh Pettit said that comments on his videos show that a lot of people may not have an accurate idea of what Alzheimer’s is like. It began with smaller things like moving things around and repeating herself, Josh Pettit said.

☆ New Alzheimer’s drug shows promise in slowing disease but may contain significant risks, study shows
▼ + stars: | 2022-11-30 | by ( The Associated Press | ) www.nbcnews.com time to read: +5 min

An experimental Alzheimer’s drug modestly slowed the brain disease’s inevitable worsening, researchers reported Tuesday — but it remains unclear how much difference that might make in people’s lives. Now the companies are providing full results of the study of nearly 1,800 people in the earliest stages of the mind-robbing disease. Also, lecanemab recipients were 31% less likely to advance to the next stage of the disease during the study. The trial is important because it shows a drug that attacks a sticky protein called amyloid — considered one of several culprits behind Alzheimer’s — can delay disease progression, said Maria Carrillo, chief science officer for the Alzheimer’s Association. Eisai said Tuesday the deaths can’t be attributed to the Alzheimer’s drug.

☆ Experimental drug appears to slow progression of Alzheimer’s disease in clinical trial but raises safety concerns
▼ + stars: | 2022-11-29 | by ( Jacqueline Howard | ) edition.cnn.com time to read: +11 min

It involved 1,795 adults, ages 50 to 90, with mild cognitive impairment due to early Alzheimer’s disease or mild Alzheimer’s disease-related dementia. Such a score is consistent with early Alzheimer’s disease, with a higher number associated with more cognitive impairment. By 18 months, the CDR-SB score went up 1.21 points in the lecanemab group, compared with 1.66 in the placebo group. Overall, there were serious adverse events in 14% of the lecanemab group and 11.3% of the placebo group. The researchers also wrote that about 0.7% of participants in the lecanemab group and 0.8% of those in the placebo group died, corresponding to six deaths documented in the lecanemab group and seven in the placebo group.

☆ Experimental therapy gantenerumab fails to slow or improve Alzheimer’s memory loss in clinical trials
▼ + stars: | 2022-11-14 | by ( Brenda Goodman | ) edition.cnn.com time to read: +3 min

Gantenerumab is part of a class of injected drugs that are designed to remove sticky protein pieces called beta amyloid from the brain. Beta amyloid buildup is a hallmark of Alzheimer’s disease. Roche said Monday that gantenerumab appears to have removed less beta amyloid from the brains of study participants than anticipated. The results for gantenerumab follow positive results for a different beta amyloid reducing drug, lecanemab. An estimated 6.5 million Americans are living with Alzheimer’s disease in 2022, according to the Alzheimer’s Association.

☆ Alzheimer’s drug slows progression of cognitive decline in clinical trial, drugmakers say
▼ + stars: | 2022-09-27 | by ( Amanda Sealy | ) edition.cnn.com time to read: +4 min

CNN —A monoclonal antibody treatment for Alzheimer’s disease called lecanemab slows the progression of cognitive decline by 27% compared with a placebo, drugmakers Biogen and Eisai said Tuesday. Alzheimer’s is a very heterogeneous disease.”But he says that does not diminish the potential significance of the trial. “In the past, reducing amyloid in the brain has not always been tied to cognitive improvements or any meaningful clinical improvements. Biogen is also the company behind another Alzheimer’s drug, Aduhelm, which was controversially approved by the FDA in June 2021. Aduhelm was the first new Alzheimer’s drug approved in nearly 20 years, but there were questions about its efficacy and cost.

As yet another Alzheimer's drug targeting plaque buildup in the brain fails to improve cognition in patients, leading scientists said a significant shift is underway in the search for effective treatments for the disease. By 2050, that number is projected to rise to nearly 13 million, according to an estimate from the Alzheimer’s Association. Alzheimer’s disease is often referred to as “Type 3 diabetes,” a brain-specific form of diabetes that is the result of the brain’s neurons lacking glucose, said John Didsbury, the CEO of T3D Therapeutics. Data from the longest-ever phase 3 trial of exercise on cognition released at the conference on Tuesday found that exercise may stall cognitive decline in Alzheimer’s patients. He said it’s only a matter of time before we see more research discoveries that show potential for slowing Alzheimer’s disease, possibly within the next year or two.

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