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The experimental drug lecanemab has indicated a slowing of cognitive decline progression by 27% in patients with early-stage Alzheimer’s, according to a study published this week in the New England Journal of Medicine.
"These findings show that lecanemab offers promise for people with early Alzheimer’s disease, with a significant slowing of decline and a reasonable safety profile," the study’s lead researcher, Dr. Christopher H. Van Dyck, told Fox News Digital in an interview.
Van Dyck is director of the Alzheimer’s Disease Research Unit and a professor of psychiatry, neurology and neuroscience at the Yale University School of Medicine.
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In the study, Van Dyck’s researchers said the drug lecanemab "reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months — but was associated with adverse events."
In this May 19, 2015, file photo, a doctor points to PET scan results that are part of a study on Alzheimer's disease at a hospital in Washington. Scientists know that long before the memory problems of Alzheimer's become obvious, people experience more subtle changes in their thinking and judgment. (AP Photo/Evan Vucci)
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, considered a major culprit in Alzheimer's disease, according to experts.
'Associated with less clinical decline'
The study included 1,795 participants who had early Alzheimer’s disease.
Of the participants, 898 received lecanemab, while 897 received a placebo in 235 sites located in North America, Asia and Europe from March 2019 to March 2021, according to the study.
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The participants were given lecanemab intravenously every two weeks over an 18-month period.
"Analyses at 18 months 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 slower progression in cognitive decline.
The investigators relied on a tool that measures cognitive impairment. It's called the Clinical Dementia Rating-Sum of Boxes (CDR-SB) — it follows the participants' progress.
The average baseline scores were approximately 3.2 in both the lecanemab and placebo groups. A score of 0.5 to 6 is consistent with early Alzheimer’s disease, according to the researchers.
The headquarters of Biogen Inc. are shown in March 2020 in Cambridge, Massachusetts. Together with Eisai Co. Ltd., Biogen developed the new drug. (AP Photo/Steven Senne, File)
After 18 months of treatment, the average score of the lecanemab group went up by 1.21 points, compared to patients in the placebo group — who saw their score go up by 1.66 points.
The lecanemab group reflected slower progression in cognitive decline.
Some participants did experience adverse events, the researchers noted.
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Approximately 20% of patients receiving lecanemab experienced brain swelling or brain bleeding, according to the study.
Lecanemab is up for FDA approval in early 2023.
Eisai said two deaths occurred, though they were not considered linked to lecanemab.
Officials at the Alzheimer’s Discovery Drug Foundation (ADDF) said in a released statement that lecanemab, which is up for FDA approval in early 2023, represents a positive step toward treatment of the disease and "welcomed news for the millions of patients and families living with Alzheimer’s."
Said one leading expert in Alzheimer's about the new findings, "We have a lot of ground to cover to get from the 27% slowing [that] lecanemab offers to our goal of slowing cognitive decline by 100%." (iStock)
Dr. Howard Fillit, co-founder and chief science officer at the ADDF, also said in the statement, "But this is only a start to stopping Alzheimer’s in its tracks. We have a lot of ground to cover to get from the 27% slowing [that] lecanemab offers to our goal of slowing cognitive decline by 100%."
The ADDF statement said amyloid-clearing drugs are part of the solution in addressing Alzheimer’s disease.
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Yet further development is needed of a new generation of medications 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 matched to each patient’s underlying pathologies is the answer and our best hope to give patients long-lasting relief from this insidious and progressive disease," Fillit said in the released statement.
The Alzheimer’s Association also released a statement regarding the phase three-trial results.
One expert who was not involved in the study told Fox News Digital she was excited to see the statistically significant difference between the lecanemab and placebo groups in the study — but cautioned that more research on the Alzheimer's drug is needed. (iStock)
On its website, the group said it was encouraged by the global clinical trial of lecanemab.
It said the study "confirms this treatment can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease. The Alzheimer’s Association calls for the Food and Drug Administration’s accelerated approval of lecanemab."
The organization also noted, in part, "These peer-reviewed, published results show lecanemab will provide patients more time to participate in daily life and live independently. It could mean many months more of recognizing their spouse, children and grandchildren."
"Statistically significant does not always mean practically significant, especially not in the setting of significant risks."
Dr. Marzena Gieniusz, medical program director of the Alzheimer’s and Dementia Care (ADC) Program at Northwell Health on Long Island, New York, commented on the findings.
Dr. Gieniusz, who was not involved in the study, said she was excited to see the statistically significant difference between the lecanemab and placebo groups in the study — but cautioned that more research on the drug is needed.
"Statistically significant does not always mean practically significant, especially not in the setting of significant risks, which were noted in the study, as well as the risks not yet evident — including the potential for increased hospitalizations, unnecessary interventions, etc."
"The FDA is expected to decide whether to grant accelerated approval to lecanemab by January 6, 2023," said the Alzheimer's Association. (iStock)
Gieniusz also told Fox News Digital, "Although I am glad to see the results so far, I am eager to learn more, including about the safety and efficacy, before meaningfully exploring 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 that researchers need participants.
"The next steps in our evaluation of this treatment will certainly be to go still earlier to asymptomatic, at-risk individuals." (The trial in preclinical Alzheimer’s disease has been underway since 2019, but is behind in enrollment.)
Van Dyck said he is "optimistic" that the "results will spur interest and enrollment and allow us to complete that important study."
Van Dyck also said he is "optimistic" that the "results will spur 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 that can be substantially enlarged by treating individuals before much damage occurs and significant symptoms begin."
Also, according to the Alzheimer’s Association, there's a potential costly problem due to a Centers for Medicare and Medicaid Services (CMS) policy that could block access to the 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.
"Should the FDA do so, the current CMS policy will prevent thousands and thousands of Medicare beneficiaries with a terminal, progressive disease from accessing this treatment within the limited span of time they will have to access it."
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The association said CMS pledged to move quickly to modify the policy if new evidence was presented.
Now, given the new evidence, "CMS can begin its review immediately," the association said. "The Alzheimer’s Association calls on CMS to revise its policy with the utmost urgency."