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Experimental Alzheimer’s drug may slow disease progression, but there are risks: experts

Experimental Alzheimer’s drug may slow disease progression, but there are risks: experts

The experimental drug lekanemab showed a slowing of the progression of cognitive decline by 27% in patients with early stage of Alzheimer’s diseaseaccording to a study published this week in the New England Journal of Medicine.

“These findings show that lecanemab holds promise for people with early Alzheimer’s disease, with significant slowdown in decline and a reasonable safety profile,” said the study’s lead researcher, Dr. Christopher H. Van Dyck, in an interview with Fox News Digital.

Van Dyck is director of the Alzheimer’s Disease Research Unit and professor of psychiatry, neurology, and neuroscience at Yale University School of Medicine.

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In the study, Van Dyck researchers said the drug lekanemab “reduced amyloid markers in early Alzheimer’s disease and resulted in moderately less decline in cognition and function compared to placebo at 18 months—but was associated with adverse events.”

In this May 19, 2015 file photo, a doctor points to the results of a PET scan as part of an Alzheimer’s study at a hospital in Washington. Scientists know that long before Alzheimer’s memory problems become apparent, people experience more subtle changes in their thinking and judgment.
(AP Photo/Evan Vucci)

Pharmaceutical company Eisai Co. Ltd. and Biogen Inc.developed a cure.

The drug is a monoclonal antibody – it interferes with the formation of amyloid plaque, which is considered the main culprit in Alzheimer’s disease, according to experts.

‘Associated with less clinical decline’

The study involved 1,795 participants who had early onset Alzheimer’s disease.

Of the participants, 898 received lekanemab, while 897 received placebo at 235 sites in North America, Asia and Europe from March 2019 to March 2021, according to the study.

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Participants were given lekanemab intravenously every two weeks in a period of 18 months.

“Analyses at 18 months showed dose- and time-dependent amyloid clearance with lekanemab, and the drug was associated with less clinical decline in some measures than placebo,” the researchers said in the published study.

The lekanemab group reflected a slower progression of cognitive decline.

The researchers relied on a tool that measures cognitive impairment. It’s called the Clinical Dementia Rating-Sum of Boxes (CDR-SB) — it tracks participants’ progress.

Mean baseline scores were approximately 3.2 in both the lecanemab and placebo groups. According to the researchers, a score of 0.5 to 6 is consistent with early Alzheimer’s disease.

Biogen Inc. Headquarters  was shown in March 2020 in Cambridge, Massachusetts.  Together with Eisai Co.  Ltd., Biogen has developed a new drug.

Biogen Inc. Headquarters was shown in March 2020 in Cambridge, Massachusetts. Together with Eisai Co. Ltd., Biogen has developed a new drug.
(AP Photo/Steven Senne, File)

After 18 months of treatment, the lekanemab group’s average score increased by 1.21 points, compared with patients in the placebo group — whose score increased by 1.66 points.

The lekanemab group reflected a slower progression of cognitive decline.

Some participants experienced adverse events, the researchers noted.

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According to the study, approximately 20% of patients receiving lecanemab experienced brain swelling or bleeding in the brain.

Lecanemab is up for FDA approval in early 2023.

Eisai said two deaths have occurred, although they are not believed to be related to lekanemab.

Alzheimer’s Discovery Drug Foundation (ADDF) officials said in a statement that lekanemab, which is on FDA approval in early 2023, represents a positive step toward treating the disease and is “welcome news for the millions of patients and families living with Alzheimer’s disease.”

A leading Alzheimer's expert said of the new findings, "We have a lot of ground to cover from the 27% slowdown. [that] lekanemab offers our goal of slowing cognitive decline by 100%."

One leading Alzheimer’s expert said of the new findings: “We have a lot of ground to make up from the 27% slowdown [that] lekanemab offers our goal of slowing cognitive decline by 100%.
(iStock)

dr. Howard Fillit, co-founder and chief scientific officer at ADDF, also said in a statement, “But this is just the beginning of stopping Alzheimer’s. slowing down [that] lekanemab offers our goal of slowing cognitive decline by 100%.

The ADDF statement says that amyloid-clearing drugs are part of the solution to Alzheimer’s disease.

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However, further development of a new generation of drugs that can target specific pathologies that contribute to the disease is needed.

The Alzheimer’s Association said it was encouraged by the global clinical trial of lekanemab.

“Unique drug combinations tailored to each patient’s underlying pathology are the answer and our best hope to provide patients with long-term relief from this insidious and progressive disease,” Fillit said in a statement.

The Alzheimer’s Association also released a statement regarding the results of the three phase trials.

One expert not involved in the study told Fox News Digital she was excited to see a statistically significant difference between the lekanemab and placebo groups in the study — but cautioned that more research is needed on the Alzheimer's drug.

One expert not involved in the study told Fox News Digital she was excited to see a statistically significant difference between the lekanemab and placebo groups in the study — but cautioned that more research is needed on the Alzheimer’s drug.
(iStock)

On its website, the group said it was encouraged by the global clinical trial of lekanemab.

It said the study “confirms that this treatment can significantly change the course of the disease for people in the earliest stages of Alzheimer’s disease. The Alzheimer’s Association is calling for expedited approval of lekanemab by the Food and Drug Administration.”

The organization also noted, in part, “These peer-reviewed, published results show that lekanemab will give patients more time to participate in daily life and live independently. This could mean many months more recognition their spouse, children and grandchildren.”

“Statistically significant does not always mean practically significant, especially not in the context of significant risks.”

dr. Marzena Gieniusz, medical program director of the Alzheimer’s and Dementia Care Program (ADC) at Northwell Health on Long Island, New Yorkcommented on the findings.

Dr Gieniusz, who was not involved in the study, said she was excited to see a statistically significant difference between the lekanemab and placebo groups in the study – but cautioned that more research is needed on the drug.

“Statistically significant does not always mean practically significant, especially not in the context of significant risks noted in the study, as well as risks not yet evident — including the potential for increased hospitalizations, unnecessary interventions, etc.”

"The FDA is expected to decide whether to grant accelerated approval for lekanemab by January 6, 2023." the Alzheimer's Association announced.

“The FDA is expected to decide whether to grant accelerated approval for lecanemab by January 6, 2023,” the Alzheimer’s Association said.
(iStock)

Gieniusz also told Fox News Digital, “While I’m pleased to see the results so far, I’m eager to learn more, including safety and efficacy, before meaningfully researching and considering the practical risks, benefits, and alternatives of this drug.”

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Van Dyck of the Alzheimer’s Disease Research Unit told Fox News Digital that further research is currently underway — and researchers need participants.

“The next steps in our evaluation of this treatment will certainly be to go even earlier to asymptomatic, at-risk individuals.” (A preclinical Alzheimer’s disease trial is ongoing as of 2019, but enrollment is late.)

Van Dyck said he was “optimistic” that “the results will stimulate interest and enrollment and allow us to complete this important study.”

Van Dyck also said he was “optimistic” that “the results will stimulate interest and enrollment and allow us to complete that important study. In addition to the important effects in early symptomatic AD, we would like to know if this can be significantly increased by treating individuals before it occurs major damage and significant symptoms begin.”

Also, according to the Alzheimer’s Association, there is a potentially costly problem with the Centers for Medicare and Medicaid Services (CMS) a policy that could block access to treatment if the FDA approves it.

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“The FDA is expected to decide whether to grant accelerated approval to lecanemab by January 6, 2023,” the association said.

“If the FDA does so, current CMS policy will prevent thousands and thousands of Medicare beneficiaries with terminal, progressive disease from accessing this treatment for the limited time they will have to access it.”

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The association said CMS has pledged to quickly change the policy if new evidence is presented.

Now, given the new evidence, “CMS can begin its review immediately,” the sources said. “Alzheimer’s Association Urges CMS to Urgently Revise Policy.”





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