Big News, Money in Neurostimulation for Cognitive Decline; Pharma Not Worried
AFAIK Dispatch #9
Alzheimer’s Families for Action, Innovation and Knowledge
Cognito Therapeutics just announced a $73 million funding round to support clinical trials of their GammaSense neuromodulation treatment. Early studies showed significant slowing of cognitive decline (though not reversal). A recent study of the general gamma frequency approach did not confirm efficacy in mice studies, but some informative discussion can be found here.
Meanwhile, gold fever continues to grip the pharmacological business approach.
Losers — Solanezumab — “Eli Lilly said that solanezumab failed to clear plaque or halt accumulation of amyloid in people with the preclinical stage of Alzheimer’s disease, putting a final nail in the coffin for the anti-amyloid monoclonal antibody programme.”
Winners — “Eisai projects over $7 billion in Leqembi sales in 2030” after accelerated approval was granted. That’s a lotta potatoes — kinda dwarfs $73 million.
Eisai and Biogen said Monday that the US Veterans’ Health Administration (VHA), part of the Department of Veterans Affairs (VA), is providing coverage of Leqembi (lecanemab-irmb) to veterans living with early stages of Alzheimer’s disease. The VA has added the anti-amyloid-beta protofibril antibody, which secured accelerated FDA approval in January, to its list of nonformulary drugs.
The decision makes VA the first major insurer to agree to pay for the drug since its approval by US regulators earlier this year. Medicare has so far restricted use of amyloid-directed monoclonal antibodies to patients in certain clinical studies (and) late last month, the Centers for Medicare and Medicaid Services (CMS) rejected a request to provide broader coverage for new Alzheimer’s treatments, but said it would “expeditiously review any new evidence…that could lead to a reconsideration and change” in its policy.
So, are we winning or losing? Some commentary on that question here — note how it is 100% about proposed drug treatments.
This pharma frenzy is all happening despite recent reports that, while dementia rates are falling in the population, amyloid plaque levels remain the same.
Why have plaque and tangle burden not dropped off at the same time? Dozens of drugs that remove Aβ plaque (and also tangles in the case of semagacestat) have not improved cognition and, in some cases, accelerated progression of the disease (Espay et al., 2021). Maybe Aβ plaque is not the cause of Alzheimer’s after all.
I’m still keeping an eye out for follow-on stories about possible fraud in the basis of the amyloid theory, reported in AFAIK #4.
it seems now there is new evidence that the amyloid plaque theory of the disease, which drove most pharmaceutical research over the last ten years, may have been based on fraudulent evidence!! More discussion and reaction to this news is here.
Most recent story I can find is this:
The original paper is now currently the focus of an investigation by the editorial team at Nature, which promises an editorial response to the allegations in due course
Not the urgency one might hope for…
For past dispatches, see the AFAIK Archive.