Could FDA-approved Alzheimer drug reduce risk of future memory problems? Get paid to check
Florida is partaking in a global clinical trial to test whether Lecanemab, the first drug fully approved to treat early Alzheimer’s, can benefit people at risk of developing the disease even before they begin to experience memory problems.
The global trial, funded by the National Institutes of Health in partnership with the Japanese pharmaceutical company Eisai, which worked with Biogen to create the drug, is recruiting adults across the country, including in Miami-Dade County, to be in the four-year study.
The U.S. Food & Drug Administration approved Lecanemab, sold under the brand name Leqembi, on July 6. While not a cure, the monoclonal antibody can be used to help slow the disease progression in people with early Alzheimer’s. Medicare will cover much of the drug’s $26,500 cost, but the FDA required a black-box warning on the label, stating “serious and life-threatening events” may occur, although rarely. Brain bleeds can also develop, the agency noted.
Now, researchers want to test whether the treatment can help those at risk of developing Alzheimer’s, even before symptoms begin.
“Out of the 6 million Americans right now living with Alzheimer’s in the United States, it’s a common theme that the disease can start 20 years before they actually show symptoms. What that means is that there’s a window of time that we’re trying to now get ahead of using the drug,” said David Cazares, a clinical research associate at the University of South Florida in Tampa at the Byrd Alzheimer’s Institute, which is participating in the study.
Here’s what to know:
How does the new Alzheimer’s drug work?
Doctors believe Alzheimer’s disease is caused by an abnormal tangled buildup of proteins, known as amyloid and tau, in and around brain cells. The over-production of these proteins disrupts communication between the cells, affecting memory, recall, language and other brain functions.
Lecanemab works to reduce amyloid plaques in the brain of people with early Alzheimer’s, delaying a person’s cognitive decline. Results from the drug’s clinical trial suggest that it slowed cognitive decline for about five months over an 18-month period.
The FDA gave accelerated approval last year to another similar Alzheimer treatment, Aducanumab, sold under the brand name Aduhelm. But some FDA experts and others said there was not enough evidence that the drug works, and Medicare restricted the drug only to those enrolled in qualifying clinical trials. The drug is undergoing further testing.
Other treatments are also in the works. On Sunday, Acumen Pharmaceutical announced that its experimental drug passed an early safety test and was now advancing to a larger trial.
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Where is the study being conducted?
The study is enrolling patients at 100 locations worldwide, with nearly 75 of the sites in the United States and Canada.
In Florida, there are 12 sites enrolling patients, including the Mayo Clinic in Jacksonville and the University of South Florida’s Health Byrd Alzheimer’s Institute in Tampa. Three sites are in Miami-Dade County and have staff that speak Spanish:
▪ Advanced Clinical Research Network, 1221 SW 27th Ave, Suite 301 in Miami
▪ Gonzalez MD & Aswad MD Health Sciences, 3401 NW Seventh St in Miami
▪ Wien Center for Clinical Research at Mount Sinai Medical Center, 4302 Alton Road in Miami Beach
There are no research sites in Broward or the Florida Keys. There is one in Palm Beach County:
▪ Brain Matters Research, 800 NW 17th Ave in Delray Beach
Who can enroll in the study?
Researchers are looking for healthy adults ages 55-80 who have not been diagnosed with Alzheimer’s or another dementia.
Those interested in enrolling will undergo a blood test to determine whether they have “intermediate” or “elevated” levels of amyloid, the Alzheimer-causing protein, according to Cazares.
Another thing to keep in mind: In order to participate in this four-year study, you’ll need to have a study partner, such as a family member or friend, who can participate in one study visit every year during the trial’s duration.
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How does the study work?
A tailored dose of lecanemab will be given to patients by IV, though not every patient will actually be given the drug. Some patients will receive placebo.
Treatment frequency will depend on how much amyloid build-up a patient has:
▪ If you have intermediate levels of amyloid — Once every four weeks for four years.
▪ If you have elevated levels of amyloid — Once every two weeks for about two years and then once every four weeks until the study is completed.
Researchers will have patients undergo brain scans to check amyloid levels, along with other tests, to track their health throughout the study, said Cazares. Expect to have in-person and telephone visits every two to four weeks.
Will I get paid?
Yes. Anyone who participates in the study will be paid $50 per required visit, according to the study’s website. The study partner will also be paid $50 per required visit.
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How to enroll
To enroll or learn more, visit AHEADstudy.org.
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This story was originally published July 18, 2023 at 5:00 AM.
