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

The experimental drug lecanemab showed a 27% slowing of the progression of cognitive decline in patients with early-stage Alzheimer’s disease, according to a study published this week in the New England Journal of Medicine.

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

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, the Van Dyck researchers said the drug lecanemab “reduced amyloid markers in early Alzheimer’s disease and caused moderately less decline in measures of cognition and function than placebo at 18 months – but was associated with adverse events”.

Pharmaceutical companies Eisai Co. Ltd. and Biogen Inc. developed the drug.

The drug is a monoclonal antibody – it interferes with the formation of amyloid plaque, believed to be one of the main culprits of Alzheimer’s disease, experts say.

“Associated with less clinical decline”

The study included 1,795 participants with early-stage Alzheimer’s disease.

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

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Participants received lecanemab intravenously every two weeks over an 18-month period.

“The 18-month analyzes showed dose- and time-dependent clearance of amyloid with lecanemab, and the drug was associated with less clinical decline on some measures than placebo,” the researchers said in the published study.

The lecanemab group reflected a slower progression of cognitive decline.

Investigators 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 the lecanemab and placebo groups. A score of 0.5 to 6 corresponds to an early stage of Alzheimer’s disease, according to the researchers.

After 18 months of treatment, the mean score of the lecanemab group increased by 1.21 points, compared to patients in the placebo group – who saw their score increase by 1.66 points.

The lecanemab 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 hemorrhage.

Lecanemab is awaiting FDA approval in early 2023.

Eisai said two deaths occurred, although they were not considered lecanemab-related.

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

ADDF co-founder and chief scientific officer Dr. Howard Fillit also said in the statement, “But this is just the start to stopping Alzheimer’s disease in its tracks. We have a long way to go. browse to get 27% slowdown [that] lecanemab meets our goal of slowing cognitive decline by 100%. »

The ADDF statement indicates that anti-amyloid drugs are part of the solution to fighting Alzheimer’s disease.

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Yet there is a need to pursue the development of a new generation of drugs that can target specific pathologies that contribute to the disease.

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

“Unique drug combinations tailored to each patient’s underlying pathologies are the answer and our best hope of giving patients lasting relief from this insidious and progressive disease,” Fillit said in the released statement.

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

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

He said the study “confirms that this treatment can significantly alter disease course in people in the early stages of Alzheimer’s disease. The Alzheimer’s Association calls for expedited approval of lecanemab by the Food and Drug Administration”.

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

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

Dr. Marzena Gieniusz, medical program director for the Alzheimer’s and Dementia Care (ADC) program at Northwell Health in Long Island, New York, commented on the results.

Dr Gieniusz, who was not involved in the study, said she was delighted to see the statistically significant difference between the lecanemab and placebo groups in the study – but warned that more research into the drug was needed. required.

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

Gieniusz also told Fox News Digital, “While I’m happy to see the results so far, I’m looking forward to learning more, including safety and efficacy, before exploring and d to meaningfully examine the practical risks, benefits, and alternatives of this drug.”

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

“The next steps in our evaluation of this treatment will certainly be to go even earlier in asymptomatic people at risk.” (The trial in preclinical Alzheimer’s disease has been ongoing since 2019, but is behind in recruiting.)

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 this important study. be significantly expanded by treating individuals before significant damage occurs and significant symptoms begin.”

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

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“The FDA is expected to decide whether or not to grant expedited approval to lecanemab by January 6, 2023,” the association said.

“If the FDA did this, CMS’s current policy would prevent thousands upon thousands of Medicare beneficiaries with terminal and progressive illnesses from accessing this treatment within the limited amount of time they will have to access it.”

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The association said CMS is committed to moving quickly to change the policy if new evidence is presented.

Now, given the new evidence, “CMS can begin its review immediately,” the associate said. “The Alzheimer’s Association calls on CMS to review its policy as a matter of urgency.”