Alzheimer's disease facts


Minna Packer December 3, 2018 at 5:02 am

While we all wish a drug could slow progression but Alzheimer’s is such a multifactorial disease, that involves brain inflammation and progressive loss of neurons. It has been linked to infection in the brain, and the amyloid theory is only one of others. Ultimately until scientists figure out what causes the disease, they won’t be able to synthesize a drug to stop it.

Lane Simonian wrote this on Alzconnected in July 2018 in regards to the BAN2401 trial.

“Biogen is a company that seems to be manipulating data. In its trial with Aducanumab, it released data on all its doses except the 6 mg dose. Four months later it released the data for the 6 mg. dose which did not significantly effect the progression of the disease. When did the company know this?

In the current Aducanumab trial, Biogen increased the trial size in the midst of the trial, because it apparently was not getting the results it wanted. In the BAN2401 it changed statistical methods because it was not getting the results that it wanted.

The number of dropouts in the ApoE4 group also raises concerns not only about the safety of Biogen’s anti-amyloid drugs, but also the significance of the results. There are relatively high rates of dropouts in the ApoE4 group due to adverse effects such as endema (brain swelling). In the earlier trial for Aducanumab, about 55 percent of those with the ApoE4 gene developed endema in the highest dose group. In the BAN2401 trial, 15 percent of those with the ApoE4 group developed endema. When people with the ApoE4 gene dropout of a trial or drop down to a lower group, it is significant because people with the ApoE4 gene progress more rapidly during the early stages of Alzheimer’s disease. Exactly how much of the slowing down of the disease was due to the drug and how much of it was due to fewer ApoE4 participants in the highest dose groups is hard to calculate. But when this is taken into account, the effects to Biogen’s drugs are less impressive than they first appear.”


Finlay Cedar March 7, 2019 at 5:02 am

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