NEW YORK (PIX11) — Alzheimer’s disease is regarded as the seventh largest killer of Americans.

One in 10 has the disease that robs them of their cognitive abilities. There is no known cure. But there is some excitement over a controversial new drug just given accelerated approval by the Federal Food and Drug Administration.

The pharmaceutical companies that developed Lecanemab, a monoclonal antibody, said it slows the progression of cognitive decline in early-stage cases. But some in the medical community are critical of the FDA approval, maintaining it needs more study because the risks outweigh the benefits.

In clinical trials involving almost 1,800 people with early onset of Alzheimer, Lecanemab targeted a protein in the brain known as amyloid, thought to be the most toxic brain cells long suspected as the main cause of the disease.

Dr. Manisha Parulekar, Director of Hackensack University Medical Center’s Center for memory loss and brain health, feels the new drug is a breakthrough advance in efforts to control the progression of Alzheimer’s.

She explains, “This particular medication dissolves the amyloid plague and slows down the cognitive decline.” She adds, “the impact of this medication is helping improve 40 percent, which is a pretty big number and is helping to delay the onset of Alzheimer’s by 18 months.”

Others are not as optimistic. Dr. Phil DeFina, a neuroscientist and founder of the International Brain Research Foundation, doesn’t believe the drug should have been approved.

“This has to be further studied,” he declares.

A number of people in the medical community agree, including twelve researchers who suggested the clinical benefits of the drug are uncertain. They question whether the benefits outweigh the risks.

Dr. DeFina claims, “the antibody may weaken blood vessels in the brain as it attacks amyloid plaques and may cause hemorrhaging in the patient.”

Critics foster their argument by citing reports of at least three recent deaths of participants in phase three of clinical trials.

The FDA responded to our inquiry, telling us in a statement:

Patient deaths are no uncommon in clinical trials, but it is important to note that patients with Alzheimer’s disease tend to be older, with many of them having pre-existing conditions that may factor into the medical outcome.

The FDA also told us the agency stands behind its approval of the drug and that “The agency has carefully reviewed the data and determined that the benefits of the drug outweigh the risks.”

Dr. Parulekar agrees.

“This medication is not for everyone,” she said, “but for those with mild dementia, if we do careful patient selection and monitor them, it does look the like the benefits outweigh the risks.”

Dr. DeFina, on the other hand, maintains, “Whether or not this drug can actually have a significant impact on slowing cognitive decline still needs to be evaluated further.”

The new drug has to be administered by injection every two weeks. it is costly, estimated at more than $20,000 dollars a year for treatment. Medicaid and health insurance carriers are still reviewing whether or not to provide coverage. Despite the drawbacks, researchers feel the new drug gives them hope that this is another step closer to eventually finding a cure for Alzheimer’s.