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Medical community hopeful following FDA's accelerated approval for Alzheimer's disease treatment

GAINESVILLE, Fla. – Local doctors and nurses say they are encouraged by Lecanemab, sold under the brand name Leqembi, an Alzheimer’s disease treatment approved by the Food and Drug Administration in January.

Alzheimer’s disease is the seventh leading cause of death in the U.S., according to the Centers for Disease Control and Prevention. The disease is a type of dementia notable for inflicting serious memory loss. In most people with the disease, symptoms first appear in their mid-60s. Nearly $4 billion is spent annually on Alzheimer’s research, according to the National Institutes of Health.

Al’z Place by ElderCare of Alachua County is an adult day care center in Gainesville for patients with Alzheimer’s disease or severe memory impairment. The facility provides Alzheimer’s patients under medical supervision with cognitive games, hot lunches and therapeutic activities.

“My role is very rewarding,” said Al’z Place nurse manager Jessica Burley. “I give the family members caring for a patient with Alzheimer’s dementia or a cognitive disorder the opportunity to have alone time. It’s a blessing in both. I think this approval [of Leqembi] will be good for the research end and people will be open to doing more of it.”

The treatment was granted accelerated approval from the FDA, which is a pathway that allows for provisional approval of drugs that treat serious illnesses for which other treatments are not available or functional. Results from recent clinical trials show that the newly approved treatment is a significant starting point for greater discovery in the future.

Kim Giberti is a geriatric nurse and senior director of health services at The Village Gainesville Senior Living Community and has been a member of the Central and North Florida Chapter of the Walk to End Alzheimer’s Committee for the past five years.

“To me, it’s really important and really exciting that we’ve made some progress,” Giberti said. “This disease affects so many people and has no boundaries. Creating the awareness is half the battle.”

The newly approved drug, Leqembi (lecanemab-irmb), is part of a new classification of medications approved as a treatment for Alzheimer’s disease. Before its approval, the drug was tested in a study of over 800 patients with mild cognitive impairment or mild dementia. Weeks after initiating the trial, the patients who received the treatment had a significant reduction of amyloid beta plaque, which are protein pieces that impair a person’s ability to remember and think.

“Billions of dollars have been spent trying to figure out how we can clear the amyloid from the brain,” said Glenn Smith, professor of clinical neuropsychology at the University of Florida. “These drugs have been tested for eight to 10 years at least. Only now are we getting the right mix of diagnostics, patient recruitment and agents to maybe see a signal here.”

Smith explains that, unlike the medication’s predecessors, Leqembi seems to help people with early stages of Alzheimer’s disease do better in terms of thinking and memory tasks while also clearing plaque from the brain.

“The new medication is not a life-changer,” said Steven T. DeKosky, deputy director of the McKnight Brain Institute at the University of Florida. “But it is proof that we can find medications that will get better and better."

Lauren is a reporter for WUFT News who can be reached by calling 352-392-6397 or emailing