Pharmaceutical companies Eisai and Biogen have announced the first results from a Phase 3 human trial testing a drug designed to treat symptoms of dementia associated with Alzheimer’s disease.
The drug seems to be successful at slowing cognitive decline, making it the first drug to ever effectively treat Alzheimer’s symptoms. A Phase 3 trial testing lecanemab recruited just under 2,000 participants in the early stages of Alzheimer’s disease with only mild cognitive impairment.
The primary goal of the trial was to evaluate each participant’s rate of cognitive decline using a measure called CDR-SB. This measure is a numeric scale designed to quantify the severity of dementia.
Trained healthcare professionals interview Alzheimer’s patients and their caregivers, generating numerical scores across six cognitive areas.
At the end of the 18-month trial those in the lecanemab group showed signs of slower cognitive decline compared to placebo.
In a press release announcing the findings, Eisai and Biogen describe the results as “Highly statistically significant.” And, from a trial perspective, these results are certainly significant, but Alzheimer’s experts are cautious in pointing out it’s unclear what this kind of slowing of cognitive decline actually means in the real world.
Rob Howard, from University College London, said these findings are certainly “An historic moment” in that they are the first clinical trial evidence of a drug slowing the symptomatic progression of Alzheimer’s.
Whether the degree of efficacy cited in the trial is actually meaningful for patients is yet to be shown, and Howard indicates the scores cited in the trial are borderline in terms of worthwhile effect.
Tara Spires-Jones from the University of Edinburgh, said if the drug can extend a patient’s quality of life, even slightly, then it would be hugely meaningful to many patients.
“While this is not a ‘cure’ in that it doesn’t bring people back to normal, slowing cognitive decline and preserving the ability to perform normal daily activities would still be a huge win because people could live well for longer with Alzheimer’s disease,” said Spires-Jones.
After years of failed clinical trials testing anti-amyloid drugs, lecanemab somewhat proves targeting this particular protein can potentially slow Alzheimer’s symptoms.
Lots of questions now arise as to exactly how this new drug can be incorporated into clinical contexts.
Tom Russ, director of Alzheimer Scotland Dementia Research Center, is looking forward to seeing more data but affirms this finding should give hope to dementia patients.
“The prospect of a disease-modifying drug for Alzheimer’s disease is an exciting one, which could improve many lives.” said Russ.