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New Phase 3 Study with positive results
Here_to_help
Posted: Tuesday, October 6, 2015 12:01 PM
Joined: 10/6/2015
Posts: 1


Biogen has been testing a medication called Aducanumab for a few years now and the results are very encouraging! Here's an article about it from this July: http://www.businesswire.com/news/home/20150722005352/en/Biogen-Presents-Data-Phase-1B-Study-Investigational#.VhP5dKOFND8

The new study is called "Engage" and it's goal is to treat VERY early Alzheimer's. So if you are worried about a family history of Alzheimer's, a study is a good way to be evaluated by a specialist without worrying about the cost. You can read more about the study on clinicaltrials.gov here is the link: https://clinicaltrials.gov/ct2/show/NCT02477800?term=221AD301&rank=1


Lane Simonian
Posted: Tuesday, October 6, 2015 3:54 PM
Joined: 12/12/2011
Posts: 5001


Welcome, Here to Help. I am going to make some negative comments regarding Biogen. Their drug in higher doses has produced some adverse affects including brain swelling. And I think they played with the numbers to produce better results. At six months, there was no significant difference between any drug dose group and the placebo group. The drop outs were highest among the Apoe4 group which usually progresses faster during the early stages of Alzheimer's disease. The company carried the results from this group forward which exaggerated the degree to which the drug slowed down the progression of Alzheimer's disease (it may not have slowed it down at all).

http://www.thestreet.com/story/13085968/1/biogen-alzheimers-and-the-biotech-mania-is-it-a-bubble.html

And the most recent results:

A 6 mg dose of Biogen's experimental Alzheimer's disease drug significantly reduced beta amyloid plaque in the brain but failed to significantly slow mental decline, potentially tempering great enthusiasm that greeted data on two other doses of the treatment earlier this year.

http://www.reuters.com/article/2015/07/23/us-health-alzheimers-biogen-idUSKCN0PW12C20150723

No phase 3 clinical trial results exist yet, but the results from phase 2 are not particularly encouraging.

Eden Desjardins
Posted: Wednesday, October 7, 2015 12:53 PM
Joined: 5/25/2015
Posts: 48


To echo Lane, I had found some reports on Biogen about a month or two ago before this post. It seems that brain swelling is a major side effect, which leads to the listed side effect "headache" - increasing/high intracranial pressure is quite dangerous, since they often lead to aneurysms.

This is worth a read : http://www.forbes.com/sites/matthewherper/2015/07/22/promising-alzheimers-drugs-disappoint-with-incremental-data/

luvliondogs
Posted: Monday, January 25, 2016 2:02 PM
Joined: 1/25/2016
Posts: 13


Hello All,

I am new and am waiting for the call to say that my husband has passed the final hurdle to be enrolled in Biogen's Phase 3 study for Aducanumab.

We're going for it. In dealing with a disease for which there is no cure, or even a treatment, to us there is no choice.  It's the best thing going right now. 

I too was concerned about the ARIA (brain  swelling), but discussed it with Dr. Ronald Petersen at Mayo in Rochester and he explained how they effectively managed the side effects in the Phase 1b trial.  In Phase 3 trial, those who are APOE 4 are not eligible for the highest dose and  my husband is APOE 3/4 so he may only get the low dose or the placebo.  Those who are getting the highest dose will be titrated up.  I'm hoping he does get the highest dose, and I'm hoping he gets some weird headaches so we know that he's getting the drug.  

I know that one man who participated in the Phase 1b and is now doing the extended part of that trial is doing very well with minimal decline.  

I joined this site hoping to be able to communicate with others about research etc. and to share experiences.  I'll keep everyone posted about how it's working for us.