BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS

[J11]

Don't understand why this thread did not generate more enthusiasm. The results from the trial were impressive. MMSE scores were almost stabilized in the treatment group during a 54 week observation.

If the connection between amyloid levels and cognition problems can be firmly established it will make Alzheimer research so much easier.
Having to do cognitive testing makes trials much more complex and it limits dosing to when people actually display cognitive problems.
If a simple amyloid scan could be done in the trials, treatment could be given well before any neuronal damage had occurred.
(The biomarker approach used so successfully in statin trials.)

[ApropoE4]

the high dosage group, which was the one showing the most (and the only statistically significant) improvements, had a very high rate of edema, with about 10% dropping out of treatment. This is great news but given the side effects I think it's going to be a while before this is applicable to still-healthy individuals.

p.s. does anyone know what the delivery mechanism was?

[GenePoole0304]

Ah, I'd been waiting for this one- Thanks, Teezer. Very encouraging. This is the first time reducing amyloid has been correlated with improvements in cognition. Fingers and toes crossed that further testing reveals more of the same. Very good news!

Really?
you have not heard about rutin?
it's cheap too.

[J11]

Trial used IV dosing.

How could they do a mass roll out with IV dosing?
They would need quite a few IV technicians.

[ApropoE4]

Trial used IV dosing.

How could they do a mass roll out with IV dosing?
They would need quite a few IV technicians.

It's very easy to train people for that. If they drop the usual (and imho silly) requirement for EMT/Paramedic training then you can get someone doing a decent job in a few days. When I was in military paramedic training course they made us stick hartmanns up each other for a week straight - believe me you don't want your bunk-mates upset at you for doing a bad job... they will retaliate.

However, it does imply time commitment and other issues. Much better if they could get this to be orally administered, of course.

[J11]

Performing millions of monthly IV doses seems undoable.
Perhaps this will be more a research trial that shows how to treat AD effectively. Another drug could then be used that had oral dosing.

So, for example, MK-8931 which is already deep into phase 3, uses oral dosing, and has shown extremely large effects on amyloid levels.
Merck had no market response on Friday.

[J11]

It will be very interesting to see who will benefit from BIIB037.

The earliest and the latest.

The recent trial looked at patients with MMSE scores from 20 to 30.

[ApropoE4]

So, for example, MK-8931 which is already deep into phase 3, uses oral dosing, and has shown extremely large effects on amyloid levels.
Merck had no market response on Friday.

That is interesting. The study isn't complete, but obviously is neither failing or they'd have stopped it already, nor amazingly successful or they'd have looked for a way to accelerate it.

[J11]

They IV dosed the placebo arm! I did not know that.

Since BIIB037 was developed from amyloid antibodies in people who did not convert to AD, it is already known that in the dose range of these people, these antibodies should be safe and effective as preventative therapy in Alzheimer's.

Why hasn't Biogen signaled this to the market?

There is a massive AD prevention market of the worried well, with money, that would be very willing to pay for this treatment, now.
Such a prevention market greatly exceeds the treatment market they are now pursuing.

[J11]

The total silence by major Alzheimer websites on this development is surprising.
These sites are continuing on as if nothing has happened.
The recent Biogen might quite possibly be the cure or the first step on the road to a cure.

Something that has also been overlooked on this thread and apparently elsewhere, is that it might now be possible to
measure the level of these protective amyloid auto-antibodies in order to predict the dementia risk of people.
This would be very useful for people in planning for their futures and possibly in helping to estimate rates of decline in
patients in AD clinical trials.