A recent article in the New York Times, How Poor Sleep Affects Your Risk of Dementia, summarizes some recent findings showing both excessively short and long sleep, as well as sleep disorders such as sleep apnea, insomnia, and rapid-eye movement (REM) behavior disorder, may be linked with risk for Alzheimer’s disease (AD) or other forms of dementia. Our recent findings from multiple studies at UCI are consistent with this interpretation. For example, in our most recent study , in collaboration with Alzheimer Biomarkers Consortium — Down Syndrome (ABC-DS) and UCI MIND investigators, we found symptoms of insomnia were more prevalent…

Today, the US Food and Drug Administration granted full clinical approval to Eli Lilly to market donanemab, brand name KISUNLA, for the treatment of early Alzheimer’s disease, including Mild Cognitive Impairment (MCI) or mild dementia. Donanemab is a monoclonal antibody against the beta-amyloid protein that accumulates in the brain of people with Alzheimer’s disease. This represents the second ever full approval for a drug that directly targets the biology of Alzheimer’s disease. Image by Andrew Harnik/AP Donanemab was shown in a Phase 2 and then in a Phase 3 trial to have a significant impact on brain amyloid burden. In…

A June 17 article in the Los Angeles Times highlighted an important safety risk associated with the new class of medications recently approved for treating Alzheimer’s disease. The drugs are anti-amyloid monoclonal antibodies and include aducanumab, donanemab, and lecanemab. Of these, only lecanemab has achieved full FDA approval at the time of writing. The side effects are collectively known as amyloid-related imaging abnormalities, or ARIA, and are potential side effects for each of these drugs, though with differential frequencies observed across the clinical trials of these medications. The specific drug side effects include what are often referred to as bleeding…

The U.S. Food and Drug Administration. Today, the FDA convened its Peripheral and Central Nervous System Drugs Advisory Committee to review the data from pivotal clinical trials of donanemab, a monoclonal antibody against the beta amyloid protein that accumulates in the brain of people with Alzheimer’s disease. One of these trials was conducted at UCI MIND. The efficacy of donanemab in treating early Alzheimer’s disease in people with Mild Cognitive Impairment and mild dementia due to Alzheimer’s disease is largely agreed to have been demonstrated. The bulk of the discussion at the meeting emphasized other aspects, such as the safety…