Success of Experimental Alzheimer's Drug Hailed As 'Historic Moment'
- 'Success of experimental Alzheimer’s drug hailed as ‘historic moment,’ The Guardian, Sept. 28, 2022. - Ed.
- Study shows cognition in early-stage patients on lecanemab declines by 27% less than those on placebo -
An experimental drug has slowed the rate of decline in memory & thinking in people with early Alzheimer’s disease in what is being described as a “historic moment” for dementia treatment. The cognition of Alzheimer’s patients given the drug, developed by Eisai & Biogen, declined by 27% less than those on a placebo treatment after 18 months. This is a modest change in clinical outcome but it is the 1st time any drug has been clearly shown to alter the disease’s trajectory. “This is a historic moment for dementia research, as this is the 1st phase 3 trial of an Alzheimer’s drug in a generation to successfully slow cognitive decline,” said Dr Susan Kohlhaas, the director of research at Alzheimer’s Research UK.
“Many people feel Alzheimer’s is an inevitable part of ageing. This spells it out: if you intervene early you can make an impact on how people progress.”
In the study, which enrolled roughly 1,800 patients with early stage Alzheimer’s, patients were given twice-weekly infusions of the drug, called lecanemab. It was also shown to reduce toxic plaques in the brain & slow patients’ memory decline & ability to perform day-to-day tasks. About 1/5th of patients experienced side-effects, including brain swelling or brain bleeding visible on PET scans, with about 3% of those patients experiencing symptomatic side-effects. The results offer a boost to the “amyloid hypothesis”, which assumes that sticky plaques seen in the brains of dementia patients play a role in damaging brain cells & causing cognitive decline.
A series of previous drug candidates had been shown to successfully reduce levels of amyloid in the brain, but without any improvement in clinical outcomes, leading some to question whether the research field had been on the wrong track. Rob Howard, a professor of old age psychiatry at Univ. College London (UCL), said: “This is an unambiguously statistically positive result & represents something of an historic moment when we see the first convincing modification of Alzheimer’s disease. God knows, we’ve waited long enough for this.” Eisai & Biogen are expected to apply for regulatory approval in the US & Europe by the end of the year.
If approved, healthcare providers will have difficult decisions about whether to fund the drug, which requires infusions every 2 weeks, & who will be eligible for it because the clinical improvements seen by patients fall just below a widely accepted benchmark. On a 14-point scale used to assess Alzheimer’s progression, patients on the drug scored 0.45 higher than those on the placebo treatment, with an Alzheimer’s patient being expected to decline by about 1 point a year. Howard said: “The accepted minimum worthwhile difference ranges from 0.5 to 1.0 points, [meaning] that there are going to be some very difficult conversations & decisions in the next weeks & months.”...
- More, https://www.theguardian.com/society/2022/sep/28/alzheimers-disease-progression-slowed-by-new-drug-lecanemab
- Also: AP News, https://www.democraticunderground.com/10142975024
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