Dementia is a general term for loss of memory and thinking abilities that are severe enough to interfere with daily life and functioning. Alzheimer's disease, the most common cause of dementia, currently affects over six million Americans. While a cure remains elusive, some developing drugs look promising.
Up until now, medications for Alzheimer's have only addressed symptoms and have not altered the course of the illness. New drugs are slowing the progression of early Alzheimer's disease by targeting beta-amyloid, a protein in the brain that's a marker for Alzheimer's disease.
Halted studies
A few years ago in this column, I wrote about aducanumab (Aduhelm®), which was the first monoclonal antibody available.
Although studies of the drug didn't consistently show that it was effective in improving cognitive symptoms in early onset, the Food and Drug Administration (FDA) granted an accelerated approval because the drug did remove beta-amyloid and seemed to benefit a small subset of patients. Before they would grant full approval, the FDA required the manufacturer, Biogen, to conduct additional studies.
As of this writing, Biogen has halted those studies and plans to give up ownership rights of aducanumab because it hasn't been profitable--and because more promising drugs have emerged.
More monoclonal antibodies
One of those drugs is another monoclonal antibody called lecanemab (Leqembi®). It recently received full FDA approval for use in patients with early Alzheimer's disease or mild cognitive impairment who have also been shown to have beta-amyloid in their brains.
Results of well-designed studies show that lecanemab (like aducanumab) reduced beta-amyloid in the brain, but most importantly, it also slowed declines in memory and thinking in patients by about 27% after 18 months of treatment.
Patients and their families need to be cautioned that although lecanemab may slow disease progression, it does not reverse or cure dementia. It also requires patients to undergo intravenous infusions every other week and periodic brain scans to detect side effects. Some of these side effects include temporary swelling in areas of the brain that can cause nausea, headache, confusion, dizziness, seizures, vision changes, and difficulty walking. In addition, some patients have allergic reactions or infusion-related problems, such as fever and flu-like symptoms.
Other monoclonal antibodies are in development, like donanemab, which, as of this writing, is in Phase 3 of clinical trials. So far, study results have shown that 60% of subjects in the earliest stages of disease did the best, but these results are still preliminary.
Just the beginning
While these medications show much promise, we are just beginning to understand who may benefit most from them and who may be at greater risk. In addition, there have been more developments in our understanding of the causes of memory loss, which will likely reveal more opportunities for new treatments in the decade ahead.
For now, if you have memory loss or have a family member you are concerned about, please talk with a doctor about having an evaluation and a discussion of potential treatment options.
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