Friday, July 27, 2018

Cautious Optimism (and, perhaps, Controversy) Follows Results on New Alzheimer's Drug

I've learned to be skeptical about reports on new medications for Alzheimer's dementia.  The reports from drug companies come and go, often fading into obscurity.  

Nonetheless, results of a large clinical trial as reported at the Alzheimer's Association International Conference in Chicago this week seem to offer more promise.  From the New York Times' article:

The trial involved 856 patients from the United States, Europe and Japan with early symptoms of cognitive decline. They were diagnosed with either mild cognitive impairment or mild Alzheimer’s dementia, and all had significant accumulations of the amyloid protein that clumps into plaques in people with the disease, said Dr. Lynn Kramer, chief medical officer of Eisai, a Japan-based company that developed the drug, known as BAN2401, along with Biogen, based in Cambridge, Mass.

 

Many other drugs have managed to reduce amyloid levels but they did not ease memory decline or other cognitive difficulties. In the data presented Wednesday, the highest of the five doses of the new drug — an injection every two weeks of 10 milligrams per kilogram of a patient’s weight — both reduced amyloid levels and slowed cognitive decline when compared to patients who received placebo.

 

Of the 161 patients in the group taking the highest dose, 81 percent showed such significant drops in amyloid levels that they “converted from amyloid positive to amyloid negative,” Dr. Kramer said in an interview, meaning that the patients’ amyloid levels dropped from being considered high enough to correlate to dementia to a level below that dementia threshold.

The results discussed above apparently arise out of Phase II of the drug's testing.  An earlier report, in 2017, was more equivocal, as captured on the ALZforum website here.  

Further, as reported on Endpoints News, an "independent news organization reporting and analyzing the top global biotech and pharmaceutical R & D News of the day," a critical response is emerging since this week's public announcement:

But instead of cheering on evidence of success [for BAN2401], a large group of analysts last night zeroed in on a crucial change in the study that could have confounded the data presented — and now we have a brand new controversy to add to the literature of Alzheimer’s.

For more of the critique, read Eisai, Biogen Battered by Controversy over PhII Alzheimer's Study After Posting Positive Results.

https://lawprofessors.typepad.com/elder_law/2018/07/cautious-optimism-and-perhaps-controvesyr-follows-results-on-new-alzheimers-drug.html

Cognitive Impairment, Current Affairs, Dementia/Alzheimer’s, Ethical Issues, Science, Statistics | Permalink

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