A Victory Over Alzheimer's? Not So Fast

Is Biogen's Alzheimer's drug a historic achievement or red herring? There are plenty of opinions on both sides. Nonetheless, it received FDA approval despite an unanimous downvote from its own expert panel. What is going on here? No one knows, but to me, it just doesn't smell right.

The subject of an email from Rick Berke, the executive editor of STAT, reads: 'A landmark day in Alzheimer's disease." Berke then linked to an article by Adam Feuerstein and Damian Garde, which, if it's less enthusiastic, it's not by much: "FDA grants historic approval to Alzheimer’s drug designed to slow cognitive decline."

If you read only the headlines it would be perfectly reasonable to conclude that the demise of this awful disease is right around the corner. Not even the most enthusiastic supporters of Biogen's Alzheimer's drug, Aduhelm (generic name aducanumab) would agree with this, and it is entirely possible that the corner isn't even on a map. Here's why.

Aduhelm, an antibody drug, did accomplish what many experimental AD drugs could not – a measurable decrease in beta-amyloid plaque – a hallmark of the disease. It is indisputable that these plaques go hand-in-hand with AD, but it is far from clear whether the plaques are a cause of the disease or a result of it. If it's the latter, the potential utility of aducanumab will be limited; the damage will have been done.

Got this in an email a couple days ago:

Exciting News: FDA Has Approved New Alzheimer’s Treatment

This message is sent to all Alzheimer’s Association and Alzheimer’s Impact Movement board members, all Alzheimer’s Association staff, and volunteers and supporters of AIM and the Alzheimer’s Association.

The Alzheimer’s Association welcomes and celebrates today’s historic Food and Drug Administration (FDA) approval of aducanumab for the treatment of Alzheimer’s disease.

While certainly not a cure, this is the first ever FDA-approved treatment for the underlying biology of Alzheimer’s, not just the symptoms. Slowing progression for those with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease or Alzheimer’s dementia in its earliest stage offers the potential for more precious time for diagnosed individuals and their loved ones.

This new treatment approval and sustained progress in the research field benefit from years of investment and relentless dedication to our vision of a world without Alzheimer’s and all other dementia.

The advances the Alzheimer’s Association has been able to drive on behalf of our constituents, to bring us to this historic moment, are thanks to you and others who have been so supportive. I am deeply grateful to you for the role you have played to make this day possible. Thank you!

With your support, the Alzheimer’s Association has advanced research in many ways, including directly funding the tools for early detection that have facilitated development of new treatments.

Of course, as I’m sure you realize, our work is not done. The fight to end Alzheimer’s is as urgent as ever. As the leader in the quest to end Alzheimer’s and all other dementia, you can be assured that the Alzheimer’s Association will fight to ensure access to this treatment and ultimately others for all communities. We won’t stop until the day our vision becomes reality for everyone.

I look forward to sharing more with you as this treatment becomes available and others advance.

Thank you again, as always, for everything you have done and everything you continue to do to drive our mission advances and to make a difference today and tomorrow for so many others.

Sincerely,

Harry Johns
Chief Executive Officer

If you or a loved one is experiencing memory changes, the Alzheimer’s Association strongly encourages speaking with a health care provider for a thorough evaluation, diagnosis and to discuss treatment options. Visit the Alzheimer’s Association at alz.org, or reach our Helpline 24/7 at 800.272.3900.

This aducanumab is not anywhere near as exciting as

Drug Reverses Age-Related Mental Decline Within Days

Just a few doses of an experimental drug can reverse age-related declines in memory and mental flexibility in mice, according to a new study by UC San Francisco scientists. The drug, called ISRIB, has already been shown in laboratory studies to restore memory function months after traumatic brain injury (TBI), reverse cognitive impairments in Down Syndrome, prevent noise-related hearing loss, fight certain types of prostate cancer, and even enhance cognition in healthy animals.

Aducanumab merely slows progression, ISRIB restores function.

In mice...

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