During a session at the 2024 Alzheimer’s Association International Conference (AAIC), which concludes today, Ralph Carmona shared his experience of being diagnosed with mild cognitive impairment (MCI) due to Alzheimer’s disease.
While MCI can be an early stage of Alzheimer’s disease, not all people with MCI go on to develop the illness.
Now a member of the Alzheimer’s Association’s early-stage advisory group, Carmona reflected on his MCI diagnosis and subsequent enrolment into a clinical trial for Eisai/Biogen’s Leqembi (lecanemab) at Boston University (NCT01767311).
Carmona recalled how he gladly signed a consent form for the trial and was unconcerned over warnings of the potential side effects of the treatment. His stance seems particularly notable in light of the recent news that the European Medicines Agency (EMA) has put the brakes on Eisai and Biogen’s plans to launch Leqembi in Europe.
The EMA’s drug review committee, the Committee for Medicinal Products for Human Use (CHMP), recently recommended against the therapy’s approval, stating that Leqembi’s positive effect on delaying cognitive decline was “not large enough” to counterbalance the associated risk of serious adverse events.
In particular, the CHMP cited concerns over the risk of developing amyloid-related imaging abnormalities (ARIA) with Leqembi use. These are observed exclusively on MRI and can signify oedema, effusion and/or haemorrhage.
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By GlobalData
Past research has shown that Leqembi caused ARIA with oedema or effusions in 12.6% of a 698-participant group.
Ralph’s story
During a busy time in Ralph Carmona’s life, wherein the 72-year-old was running for local US government office and teaching at a local community college, his wife Vana expressed concern over what she saw as his declining mental acuity.
Ralph was in denial, but after a series of discussions with his wife, he said he embraced the challenge of going to get “checked out”.
A neurologist diagnosed Carmona with MCI, leading him to question how bad his disorder may get and what could be done to stop this early-stage disease from becoming “full-blown” memory loss.
Ralph’s neurologist mentioned participation in clinical research trials and told him about the clinical study taking place at Boston University.
“Within days, I got admitted and was soon diagnosed with amyloid protein on my brain,” said Carmona.
“I became subject to bi-weekly infusions of an experimental drug for the next nine years.”
Carmona continued that he never knew whether he was on the “experimental drug” (Leqembi) or a placebo.
After around six months of receiving the infusions, Ralph’s wife told researchers that she believed he was taking Leqembi as opposed to a placebo, and that it was working.
“According to her, I was less forgetful, more attentive, and followed up on matters that we agreed upon,” said Carmona.
“Experiences like mine show how science betters life in the face of diseases like Alzheimer’s”, concluded Carmona.
“Going forward, what I’d like to see are efforts aimed more at genetic disposition and treatments that can totally eliminate, if not manage, disease-related brain changes.”
Leqembi received US market approval from the US Food and Drug Administration in July 2023. GlobalData analysts forecast that the drug will generate total sales of $12.9bn between 2023 and 2028.
