Monday, 17 February 2014

Interferons for Alzheimers

Grimaldi LM, Zappalà GG, Iemolo FF, Castellano AE, Ruggieri SS, Bruno GG, Paolillo AA. A pilot study on the use of interferon beta-1a in early Alzheimer's disease subjects. J Neuroinflammation. 2014 ;11(1):30. [Epub ahead of print]

Despite the fact that multiple sclerosis (MS) and Alzheimer's disease (AD) share common neuroimmunological features, interferon beta 1a (IFNbeta1a), the well-established treatment for the prevention of disease progression and cognitive decline in MS patients, has never been used in AD. We evaluated the safety and efficacy of IFNbeta1a in subjects affected by mild-to-moderate AD in a double-blind, randomized, placebo-controlled, multicenter pilot study.  Forty-two early Alzheimer's patients were randomized to receive either a 22 mcg subcutaneous injection of IFNbeta1a or placebo three times per week. A treatment period of 28 weeks was followed by 24 weeks of observation. IFNbeta1a was well tolerated and adverse events were infrequent and mild to moderate. Although not statistically significant, a reduction in disease progression during follow-up was measured in IFNbeta1a-treated patients by the Alzheimer's Disease Assessment Scale cognitive subscale.
Interestingly, the treatment group showed significant improvements in the Instrumental Activities of Daily Living and Physical Self-maintenance Scale. This study suggests that IFNbeta1a is safe and well tolerated in early AD patients, and its possible beneficial role should be further investigated in larger studies.
Beta interferon has failed to influence non -progressive MS, it is now tried as a DMT in Alzheimers disease another disease with progressive neurodegeneration and in this small study the conclusion should be that it does not work. 

Trends are surely meaningless 

Could it work maybe if the study was adequately powered as a trial of 42 is a low number?  We will have to wait until another study is done.  

Is it good that something is being tried or it is time to suggest that studies are done properly in the first place and give a realistic answer.  This is a debate that needs to be had in MS research as we see countless small trials moving us no where but on to the next small scale trial. It is all well and dandy talking about animal studies in the failure to translate, but it is not all the fault of the basic scientists and sometimes we need to look in the mirror

I wonder what the proposed mechanism of action was?

5 comments:

  1. Wasn't this a pilot study? I think the point of such a study is to determine if it is worth pursuing in a phase 3 trial. I guess you can start off the bat in a phase 3 trial, but it seems to me you would need justification for someone to pay for it.

    ReplyDelete
    Replies
    1. This is sort of a fair point. Yes it was a pilot study. Phase I is safety, Phase II is safety and efficacy,Phase III is efficacy. Given the known safety profile of beta interferon was this a phase I or a phase II study but is is really big enough for a phase II,

      There was no positive signal just a hint what does that mean. Does this say stop if you cant get a stop message it needs to be done at a level where you get an answer.

      Time and time again we see small MS studies that need repeating before going onwards and upwards. This wastes 2-3 years each time. why not do things properly get an answer and move one or not at all.

      We see many studies that are never followed up despite the throw away comment about further studies are needed.

      I wonder if people should have to plan how their drug studies would be advanced to people with MS before the study is started. We see too many phase I/II going now where.

      Delete
    2. Perhaps I'm being cynical, but is pharma looking for some other cash cow disease for beta interferon now that more effective MS DMTs are being developed?

      Delete
    3. You might say that, we couldn't possibly comment! ;-)

      Delete
  2. The authors declared that they have no competing interests (you can read the manuscript as it open source), although the senior author appeared to be employed by Merck Serono and the study was actually funded by Merck Serono, although it states the first author sort to get the financing.

    The issue with conflict of interest is perceived conflict could this be perceived here:-)

    ReplyDelete

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.