2023 began with hopeful news for individuals diagnosed with Alzheimer’s as well as their families and caregivers. The Food & Drug Administration (FDA) granted an “accelerated approval” for a new drug called, Lecanemab, which will be sold under its brand name Leqembi. In clinical trials, Leqembi was shown to slow the progression of early-stage Alzheimer’s disease.

Alzheimer’s is a progressive, irreversible brain disorder that damages and destroys nerve cells in the brain. Over time, the disease leads to a gradual loss of cognitive functions that affects memory, thinking and language skills. It can also cause a range of behavioral changes.

The FDA uses an accelerated approval for drugs that treat conditions where there is an unmet medical need and the drug has shown promise of a clinical benefit to patients. According to Billy Dunn, M.D., Director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research: “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

Dr. Robert Riekse is a board-certified internist, with subspecialties in palliative and hospice medicine, and geriatric medicine, and is the Medical Director of Beacon Hill at Eastgate, while also serving as the Program Director for the Trinity Health Grand Rapids Geriatric Medicine Fellowship Program. Dr. Riekse sat down with us recently to discuss Leqembi. He said the FDA’s accelerated approval of the treatment is significant. “It’s been over 20 years since there has been any development of pharmaceuticals to help those with Alzheimer’s.” Although Leqembi did slow the progression of Alzheimer’s in the clinical trial, Dr. Riekse noted, there were “better outcomes, but not faster. And while it helps prevent decline it cannot improve or reverse what has already been lost.”

Leqembi works by removing a sticky protein, called amyloid beta plaque, a marker of Alzheimer’s disease. Over 18 months, researchers tested Leqembi’s efficacy in a double-blind, placebo-controlled, study of nearly 1,800 patients with Alzheimer’s disease who exhibited mild cognitive impairment or mild dementia with confirmed presence of the amyloid beta plaque.

Study results showed that Leqembi slowed clinical decline by 27% after 18 months of treatment compared with those who received a placebo. Christopher van Dyck, MD, director of Yale’s Alzheimer’s Disease Research Unit, played a leading role in the study and said this about the effectiveness of Leqembi: “. . . Leqembi selectively targets the forms of amyloid protein that are thought to be the most toxic to brain cells.”

Participants also showed a 26% slowing of decline in a key secondary measure of cognitive function and a 37% slowing of decline in a measure of daily living compared to the placebo group. Dr. van Dyck said this about the test: “These results could also indicate a starting point for bigger effects. The data appear encouraging that the longer the treatment period, the better the effect. But we’ll need more studies to determine if that’s true.”

Study participants received Leqembi by an intravenous infusion every two weeks with the expectation that it should be taken throughout the patient’s lifetime, or at least as it appears to slow advance of Alzheimer’s. To date, Medicare has not approved the drug nor have major insurers who often follow Medicare’s lead in what medications they will cover. And, the price is hefty — $26,500 a year.

A recent article in Forbes Magazine, quoted the Institute for Clinical and Economic Review that calculated a cost-effective annual price for a typical patient should be between $8,500 to $20,600. The Institute also said what the current price for Leqembi — $26,500 annually — means to a family with limited resources. “That sum could pay for 1,000 hours of a home health aide, more than 300 days of adult day services, or six months in an assisted living facility.”

There are some side effects. About 17% of those in the trial suffered brain bleeds and 13% had brain swelling. Most of these adverse events were minor, at least for those being carefully observed in the drug trial. According to the Forbes article, some physicians worry about the effects of these bleeding episodes on people who are not under the regular care of a doctor or who may be taking blood thinners for conditions such a heart disease. In situations like that, the article concludes those individuals “should be very careful about taking Leqembi.” However, the drug will include a warning for these patients.

Despite some optimism for the promise of Leqembi and how it might slow the progression of Alzheimer’s for those in the early stages of the disease, Dr. Riekse has concerns: “The cost is out of reach for most individuals. A $12,000 annual cost would be better but it’s unavailable for individuals not in the trials and it has not been approved by Medicare or other health insurers.” He said he would consider prescribing Leqembi as long as it was not contraindicated by the use of an anti-coagulant medication in his patients due to the risk of fluid formation on the brain.