Like two other new therapies recently approved (Aduhelm & Leqembi), Donanemab will be seeking FDA approval after completing Phase 3 clinical trials. All three are monoclonal antibodies that target plaques (beta-amyloid proteins) in the brain. All three claim to show "statistically significant" results in slowing cognitive decline. However, all three also share concerning similarities:
Brain swelling
Brain bleeds
Unaffordability
In the published study (see link below), many participants in the trials could not continue due to "adverse effects". Three deaths were reported, as in one of the previous drug trials, and I wonder what would have happened if some or all of these participants with adverse effects were allowed to continue?
All three therapies offer to help those who are in the very early stages of dementia, with marginal results for a very short period of time. These infusions are expensive, lengthy (Donanemab was 76 weeks in the trial), that include PET scans, and multiple MRIs during the course of treatment...who pays for this? Leqembi actually now has an EpiPen that patients can deliver the dosage themselves. Remember, Aduhelm had an initial patient cost of $56,000/year? (They've since halved the price).
I hate to be a naysayer because so many people are holding out for hope that there is a drug out there that can help those afflicted by this terrible disease. We also know many people are willing to try anything because they are so desperately looking for some improvement in cognition. But the same question comes up time and time again: Are the risks worth the reward? Just bear in mind, there is a rush to get these drugs approved and to market. There are billions and billions (maybe trillions) of dollars at stake for these pharmaceuticals. My hope is that before people rush out to their healthcare providers and ask for these treatments, having all the information (and accurate information, not the marketing hype) can help answer the risk/reward question.
Here is the article, free to read. https://jamanetwork.com/journals/jama/fullarticle/2807533
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