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Alzheimer’s, an experimental drug shows promise

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The first drug that could slow the progression of the disease in Alzheimer’s patients has been identified. The experimental drug is called Lecanemab.

 

The drug has an antibody that targets the toxic clumps of amyloid protein that develop with the disease. The full results of the phase 3 study of the drug lecanemab (the final phase of trials in humans) have been published in the New England Journal of Medicine. The study showed that patients receiving the drug had 27% slower disease progression than those receiving a placebo, after 18 months of treatment. Though one must remain alert to the possible side effects of the drug. The risk is defined as ” non-negligible “.

About 1,800 people with early-stage Alzheimer’s took part in the study. Participants to receive the drug, intravenously every two weeks, were randomly identified, the others were given a placebo drug. The study was double-blind, meaning that neither the participants nor the researchers knew who was receiving the experimental drug and who was receiving the placebo until the end of the study.

Throughout the study, the participants’ disease progression was monitored using the Clinical Dementia Rating Scale, which assigns a patient score based on cognition and ability to live independently. The participants’ brains were also scanned for two proteins commonly associated with Alzheimer’s disease: amyloid and tau.

 

Alzheimer’s scores in both groups worsened over the 18 months of the study, but the rate of decline was slower in those who received lecanemab . Some experts are concerned that this effect may not be clinically significant. In a statement to the Science Media Centre, Rob Howard, professor of senior psychiatry at UCL, said that “none of the reported outcomes, including the primary, achieved levels of improvement acceptable to constitute a clinically meaningful treatment effect. ”.

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The success of lecanemab was also measured by the amount of amyloid and tau proteins in subjects who took the study drug compared to those who received the placebo infusion: the results showed a reduction in these proteins in those who took received lecanemab. In fact, brain amyloid levels were reduced below the threshold needed for a positive diagnosis of Alzheimer’s. However, markers of brain cell death were unaffected, indicating that amyloid in Alzheimer’s disease is only one mechanism in a complicated disease landscape.

Side effects

About one in four participants (26.6%) in the lecanemab group experienced brain swelling or bleeding in the brain (which can be small or large). STAT, a medical news website, reported that a man died of a brain hemorrhage after receiving lecanemab , citing a possible interaction with his blood-thinning medications.

 

Shortly thereafter, the journal Science reported a second death of a trial patient, also after receiving treatment for a stroke. However, the drug’s developer, Eisa, told Science: “All available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause.”

However, given the potential for patients to take the drug for the rest of their lives, more research into safety and interactions with existing drugs is needed. It is also important to find out how long- lasting the improvements in cognition are and whether the drug continues to slow the rate of decline or whether the results stabilize or even decrease. It should be noted that only patients who had a sufficient level of amyloid in their brain or spinal fluid – which requires a PET brain scan or invasive lumbar puncture – could participate in this phase 3 study. In the UK, Alzheimer’s is currently diagnosed through an interview with a doctor.

Based on earlier findings, Eisai applied to the US Food and Drug Administration for accelerated approval of the drug. The decision is expected on January 6, 2023. If the regulator grants accelerated approval, these latest results will likely support a full approval application.

  • Second death linked to potential antibody treatment for Alzheimer’s disease. (science.org)
  • Lecanemab in Early Alzheimer’s Disease. The New England Journal of Medicine. (nejm.org)
 
 

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