The 2020s have been the most impactful decade so far for the debilitating form of dementia
Categories: For Potential Participants, [Alzheimer's Disease, Alzheimer's clinical trials, Alzheimer's diagnosis, Alzheimer's disease clinical trials, Daytime sleepiness, Lack of sleep, Poor sleep, Sleep apnea, Sleep disorders]
Alzheimer’s Disease was first discovered in the early 1900s by a German doctor, Alois Alzheimer, who had the occasion to examine brain matter of a patient who had passed away after exhibiting memory loss and behavioral challenges. Over the past 100+ years since, Alzheimer’s dementia has come to affect more than 5.5 million Americans, robbing them of precious memories and severely limiting quality of life during what should be the “golden years.”
With such devastating impact on so many as they age, Alzheimer’s Disease has commanded significant attention by way of clinical research. In the 1980s it was discovered that Alzheimer’s is caused by a build-up of plaque called beta-amyloid in the brain. This plaque can disrupt normal cell functioning and lead to the symptoms exhibited by Alzheimer’s dementia – memory loss along with increasing confusion and lack of self-care ability.
In the last year alone, hundreds of clinical trials focused on the disease have been undertaken to better understand the root cause of the condition and to help limit or stall its effects. Until 2021, only two classes of drugs had been approved by the FDA to aid patients suffering with Alzheimer’s: cholinesterase inhibitors such as Aricept that can potentially ease symptoms at any stage, and a receptor antagonist, Memantine, to slow progression in those that are in an early disease state.
The 2020s however have seen more positive activity on the Alzheimer’s front than in any other previous decade. Recently a handful of clinical trials have reported positive results on the Alzheimer’s Disease landscape with two trials leading to fairly rapid FDA approvals. First out of the gate was Aduhelm, a monoclonal antibody approved in 2021 after demonstrating reduced brain plaque in patients with mild disease. The drug is delivered via a monthly infusion to help slow cognitive decline in people at the early stages of decline.
Shortly after Aduhelm was announced, the FDA issued another accelerated approval for a different monoclonal antibody demonstrated to also clear the presence of amyloid plaque in the brain. Leqembi, like Aduhelm, is given to patients with mild cognitive impairment via an intravenous infusion. In a research study with 1,800 participants diagnosed with early-stage disease, the therapy helped reduce decline in thinking by 27 percent over an 18-month period.
In 2023, a report stemming from a clinical trial of yet another monoclonal antibody, donanemab, was released showing even more promising results. In a study of 1,700 participants, more than one-third experienced slower mental decline when compared with participants on placebo. In addition, 47 percent of participants in the trial assigned to the therapy experienced stable disease, meaning disease that did not worsen, over the course of the trial. Plans are underway for an FDA review of the IV therapy drug later in 2023.
With any treatment, there are risks and benefits to be weighed based on the whole-health picture of a patient. But for Alzheimer’s patients and their loved ones, recent progress such as that reported with new monoclonal antibody therapies shown to help remove amyloid plaque are providing much needed glimmers of hope.
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