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☆ Alzheimer's diagnosis revamp embraces rating scale similar to cancer
▼ + stars: | 2023-07-16 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

July 16 (Reuters) - Alzheimer's disease experts are revamping the way doctors diagnose patients with the progressive brain disorder - the most common type of dementia - adopting a seven-point rating scale based on cognitive and biological changes in the patient. "Stage 1a is really the beginning of evidence that someone has the disease," Jack said. The new scale also includes a Stage 0 for people who carry genes that guarantee they will develop Alzheimer's. Noting the new system's similarity to cancer stages, Jack said, "There's no such thing as mild breast cancer. Jack also noted that many other conditions can cause dementia but not all dementia is Alzheimer's disease.

Persons: Clifford Jack, Eli Lilly's, Maria Carrillo, Jack, Julie Steenhuysen, Will Dunham Organizations: Alzheimer's Association, Mayo Clinic, National Institute of Aging, government's National Institutes of Health, Drug Administration, FDA, Down, Thomson Locations: Amsterdam, Rochester , Minnesota, Chicago

☆ Eli Lilly Alzheimer’s treatment donanemab slowed disease progression in clinical trial
▼ + stars: | 2023-05-03 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The Alzheimer's treatment donanemab, which is made by Eli Lilly , significantly slowed progression of the mind-robbing disease, according to clinical trial data released Wednesday by the company. Patients who took donanemab were 39% less likely to progress to the next stage of the disease during the study, according to the trial results. Dr. Daniel Skovronsky, Lilly's chief scientific and medical officer, said donanemab demonstrated the highest level of efficacy of any Alzheimer's treatment in a clinical trial. In a separate measure, patients who received donanemab showed 40% less decline in their ability to conduct daily activities at 18 months. "These are the strongest phase 3 data for an Alzheimer's treatment to date.

The drug, donanemab, met all goals of the trial. "These are the strongest phase 3 data for an Alzheimer's treatment to date," said Maria Carrillo, chief science officer for the Alzheimer's Association. In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants. It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

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."

☆ Exclusive: US to build $300 mln database to fuel Alzheimer's research
▼ + stars: | 2023-04-03 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

The platform will draw on data from medical records, insurance claims, pharmacies, mobile devices, sensors and various government agencies, they said. The database could help identify healthy people at risk for Alzheimer's, which affects about 6 million Americans, for future drug trials. The U.S. Medicare health plan for older adults will likely require such tracking in a registry as a condition of reimbursement for Leqembi. Silverberg said the data platform could also help researchers working in other disease areas understand which patients are most at risk and the impact of medications. The system would be built in a secure computing environment with a number of restrictions to ensure the privacy of people's health data, Silverberg said.

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.

☆ 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 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.

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