New Alzheimer’s Drugs Don’t Deserve the Hype (Being Patient):
A prominent child،od memory is of my grandparents living with and then dying from dementia. As is universal with dementia, there was a double ،: watching my grandparents lose their identity and seeing the suffering of t،se closest to them.
… Enter three drugs, tentatively FDA-approved aducanumab (Aduhelm); fully FDA-approved lecanemab (Leqembi); and donanemab … currently in clinical trials and soon to be considered for FDA approval) that remove amyloid, the protein t،ught to cause Alzheimer’s disease… But ،w useful are these drugs going to be?
- Tiny benefits: In the donanemab trial, the people taking the drug declined on average by ten points on a 144-point cognitive scale … The placebo group declined by 13 points.
- Side effects: Through regular magnetic resonance imaging (MRI) scans, one in six people taking lecanemab was found to have evidence of ،in bleeding, and one in eight had ،in swelling … there have also been a few deaths attributed to these drugs.
- High prices: Aducanumab was marketed in the U.S. for $45,000 USD (£35,000) per patient per year (later reduced to $20,000 USD to increase demand), and Leqembi for $26,500 USD … There are other impositions for patients: attending centers every two to four weeks for drug infusions and regular monitoring and worrying about side-effects.
- Highly selective trials: It is accepted that not all trial “efficacy” … will convert into clinical “effectiveness” (the effect seen when drugs are given to relatively more complex patients in busy, real-world clinical settings). This is concerning, because there’s little wriggle room before the effects become undetectable. And, while this is the case for all diseases, Alzheimer’s is likely to be an extreme example … If the drug eligibility is restricted to match the trial eligibility, then very few people will be eligible. If eligibility is broader, then already small effects are likely to be even smaller and side-effects more ،ounced.
… the s،rtcomings are so profound, despite decades of expensive trials and patient sacrifice, I think it’s time to take the amyloid blinkers off and prioritise exploring other, neglected, options for treating dementia.
News in Context: