Alzheimer's Drugs in Trial, Part 1

One of my friends diagnosed with Alzheimer’s recently talked with his counselor about how depressing his cognitive problems are.  He is losing hope that new Alzheimer’s drugs will be available in time to help him.  Based on media reports, his counselor said she thought he was too pessimistic, and that new treatments were around the corner. 

Should patients and families really expect new drugs to be available soon?

Last year, Pharmaceutical Researchers and Manufacturers of America (PhRMA) issued a report called Medicines in Development for Alzheimer’s Disease.   Citing industry sources and the Adis R&D Insight database, the document lists 98 Alzheimer’s medicines in clinical trials.   The document is meant as a status report, says Ed Belkin, VP of Communications and Public Affairs for PhRMA, and is not meant to advocate for any particular action.  “Patient advocacy groups are hungry to know what’s in the pipeline,” he says.  “This is a way to catalog the hefty lift being done inside America’s biopharmaceutical companies.”

The recent wave of failures of Alzheimer’s drugs in trial has heightened the sense that pharmaceutical company investment in this area is risky, reducing funding and causing companies and individuals to consider leaving the field.  So showing a little love for researchers in the pharmaceutical industry is a good thing.  “We’ve tried to convey that research scientists who come to work every day in America’s biopharmaceutical companies are committed to finding a cure for Alzheimer’s,” says Mr. Belkin.

Of the 98 drugs in the PhRMA report, six are listed as being in Phase III clinical trials.  However, three of those drugs had already failed in trials by the time the report was published.   The remaining three are anti-amyloid treatments, and one of them (bapineuzumab) is being tested only on people without the APOE4 genetic variation. 

If those Phase III trials are successful, and regulatory bodies like the U.S. Food and Drug Administration approve the drugs, they could conceivably be on the market in many countries in less than five years. 

Overall, potential treatments in Phase III have an estimated 47% chance of getting to market, which would mean that it’s likely that at least one of these three drugs will be available soon.  That estimate is for past decades and all types of drugs, though, and may not be valid for potential Alzheimer’s drugs being tested now.  If the amyloid hypothesis is flawed, as some researchers believe, the chances of success for the drugs in Phase III trials could be much lower.

What about the 38 potential treatments listed in the PhRMA report as being in Phase II trials?  With an average of 44% of drugs in Phase II transitioning to Phase III trials, and applying the 47% chance of Phase III drugs getting to market, perhaps eight of these 38 potential treatments could eventually be available.   But it would certainly be more than five years before any of these drugs now in Phase II were on the market.

So, if past experience with developing all types of drugs were a guide, then Alzheimer’s patients and families might expect to see one new treatment on the market within five years, and a handful within ten years.   Developing neurological drugs is more difficult and takes longer than other types of drugs, though.  The uncertainty about the causes of Alzheimer’s adds to the difficulty.   It’s too pessimistic to predict current trials will end in failure – we need to wait and see what the data says.  But I think it’s too optimistic to plan your life around new treatments being available anytime soon.

Comments

[A.R.]

Dear Grandpa, is a tribute to my grandpa who died on December 17th, 2010. He suffered from Alzheimer's disease for many years, which I documented through poems and stories. Recently, I have chosen to write letters to him, so he will forever be on my mind.

My site not only serves in an intimate way, but it also shows the world just how serious this disease is. Anyone who has been through, or is currently going through this experience, is welcome to comment or email me. I can answer any questions and I hope that this can be as comforting to you as it is for me.

In addition, the traffic and clicks on the advertisements will create an income, all of which will be donated to the Alzheimer’s Association to aid in research and support groups.

Please help make this dream come true. Thank you.

www.deargrandpa1.blogspot.com

[Mike Donohue]

This article appearing in the Tangled Neuron captures the reality of the progress being made in Finding the Cure. It is so unfortunate that it is taking so long, at the same time, it took so long to get a handle on Aids, we have learned much about cancer that is enormously helpful too. This is true in spite of the fact that we have not found the medication able to obliterate it able to cure it. The same is true of heart disease the other of the four loss leaders ravaging humanity.

This means we hang tight and continue the research, continue to search and continue raising the funds to do so.

It also double underlines the short term need, long on its own, to care for those of us with it. I continually ask:

Interesting, Very Interesting, about finding the cure in five or ten years; God speed your search! And, What Are You Doing For Me Today Or For The Next 9 Years As I Succumb To The Ravages Of This Disease Before You Find The Cure?

The answer to this question is only now seeing the light of day as programs are finally being produced to care, comfort and treat us who have it, remain functional and wish to continue so. This is a problem equal in kind to the catastrophe of getting the disease. If we do not have help in prolonging our functionality we quickly slide the slippery slope to oblivion that is but the halfway point of our disease.