Brain Health: August 2023

‘It’s Big-Time Progress’: Groundbreaking Alzheimer’s Drug Soon To Gain FDA Approval

Ann Marie Barron

July 4, 2023 (Staten Island Advance) STATEN ISLAND, N.Y. — A groundbreaking new Alzheimer’s drug that slows the progression of the devastating disease is expected to be approved by the Food and Drug Administration (FDA) next month, and local researchers and caregivers are optimistic.

The medication, Leqembi, a monoclonal antibody manufactured by Eisai and Biogen, is the first to reduce the amount of amyloid beta plaque in the brain, slowing down the progression of the illness. Though it can’t reverse the damage already done by Alzheimer’s disease, it can produce improvement for patients with mild symptoms, research has shown.

Leqembi has already been brought before the FDA medical board, which voted unanimously to approve it. Full board review and approval is expected in July. If approved, Leqembi would be the first disease-modifying drug ever to achieve that regulatory milestone. Currently, medications exist that treat symptoms, but none change the course of the disease.

More than 6 million Americans live with Alzheimer’s disease, the fifth-leading cause of death for adults over 65, according to the Centers for Disease Control and Prevention.

Though Leqembi is not without potential side effects, it is considered by Alzheimer’s experts to be a significant step forward in therapy for the aggressive disease.

Dr. Adam Smith, who holds a Ph.D. in a neuropsychology and is the director of research at Richmond Behavioral Associates, in Graniteville, which conducts clinical trials on promising treatments for moderate and severe dementia cases, said he and his colleagues are excited about the possibilities the new medication offers.

“It’s big-time progress,” said Smith, whose center currently is running about six clinical trials related to Alzheimer’s disease and is planning an Alzheimer’s screening in late July. “It’s very exciting because it’s the first time a drug has been shown to reduce the amyloid deposits.”

Once the FDA approves the drug, Medicare will most likely cover the treatment, but physicians will be required to provide patient treatment and demographic data before approval is granted.

Doctors have been able to legally prescribe Leqembi since January, when the FDA granted accelerated approval. But the Centers for Medicare and Medicaid Services currently will not pay for Leqembi or other similar Alzheimer’s drugs, which can cost up to $26,000 a year, unless patients are enrolled in a clinical trial.

The new treatment isn’t for everyone, Smith cautioned. His words were echoed by Dr. Theodore Strange, a board certified geriatrician and chairman of medicine at Staten Island University Hospital, who said that’s one reason he’s cautiously optimistic

It is not for patients in the advanced stages of the disease and it’s only for patients with amyloid plaque deposits, which can only be determined by a PET scan, Smith said. Not all patients experiencing dementia have such deposits, Smith said.

Yet, Strange remains optimistic, he said.

“Anything that comes out, I’m encouraged,” Strange said. “It’s something I’d like to see used in the proper circumstances.”

Strange noted that there are several causes of dementia that aren’t related to Alzheimer’s disease at all, including B-12 deficiency. And vascular dementia is caused by cigarette smoking, he said, noting that patients with these conditions won’t benefit from the new drug.

Yet, Strange said this progress is definitely a step forward in what has been a long, difficult journey.

“Anything that’s out that’s been approved by the FDA always holds promise,” he said. “With Alzheimer’s, we’re always looking for promise. Anything approved in this field is very, very hopeful.”

Potential side effects, such as brain swelling and behavioral problems, are also a concern.

Treatment with Leqembi is quite involved, Smith said, as the drug is administered intravenously twice a month. An MRI scan is required every three months to check for brain swelling, and patients must also undergo a PET scan to identify the buildup of plaque in the brain.

Yet, Smith is impressed by Leqembi, which, he said, has been shown to reduce the accumulation of plaque and deliver a 35% slowing of the clinical and functional decline caused by Alzheimer’s disease.

“It’s a significant step forward,” he said.

Early detection of the disease, before patients begin to lose Activities of Daily Living (ADLs) is critical, both Smith and Strange said.

Continuing research is looking to develop quicker and easier diagnostic tests, like a blood test Richmond Behavioral is using in clinical trials, hoping to make these available for early detection in the future, Smith said.

Strange said it’ll be many months before patients and practitioners will see the potential results. “It’ll take six months to see if someone hasn’t progressed,” he said. “It’s not like putting someone on a blood pressure pill.”


Richmond Behavioral Associates is planning to hold another screening, which will allow those concerned about Alzheimer’s to undergo testing, and potentially participate in treatment trials, free of charge.

The screening evaluations, which are held in Graniteville, involve providing a family history and then participating in a memory test, Smith said. “If there’s a concern or . . . if the screening is positive, they have trouble with their memory on testing, then we can suggest further follow up. That can be a more detailed memory test, talking to family members and possibly sending for an MRI or PET scan.”

Richmond Behavioral Associates is one of only a handful of such clinical research centers in the New York metropolitan area, Smith said.

The advantages to early detection of Alzheimer’s disease are plentiful, families of Alzheimer’s patients recently told the Advance/

“It gives the person the greatest chance of preventing further decline,” Smith said, noting that treatment, especially newer treatments like Leqembi, can begin earlier if diagnosis takes place sooner. Treatments also include lifestyle changes, managing other health conditions and checking into drug interactions.

His center is also currently doing a study attempting to identify patients before they have symptoms. Blood tests are available in that trial for those over age 65 who have a family history of the disease, he said. The blood tests identify plaque markers in the blood linked to Alzheimer’s disease.

Anyone over age 50 is invited to participate in a routine screening, which takes about 10 minutes.

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