And So It Begins - Clinical Trial Blogging Prologue

Tomorrow is visit #1 for the clinical trial Mom has been accepted into in Columbus. To save my sanity, what's left of it (thank you kitties), I am going to blog my way through this journey.

The study is being conducted by Merck. The drug in question (MK-8931 aka SCH 900931) is designed to treat Alzheimer's rather than Primary Progressive Aphasia, which Mom actually has - but PPA is rare (approximately 40,000 nationwide in 2013). And her sort isn't too common within that group being the logopenic variant. There are a limited number of research centers in the U.S. that are even looking at PPA. Northwestern in Chicago is the closest. Mayo Clinic is another and UC San Francisco is the third. That's pretty much it, so nothing nearby.

And since PPA is rare, the research money goes to the greater "need", the larger population base. I understand that, it makes a kind of mercenary sense - it's good business. But despite my understanding the way things "work", I'm not happy about it. Treatment of illness should not be driven by profit. 

PPA shares a pathology with Alzheimer's so the theory is that if this drug can slow the one disease it ought to be able to slow the other. We can only hope, and pray. The pathology is that both illnesses have two amyloid plaques that build up in the brain and cause problems. Both have the Tau version but the second plaque is different between the two. Where in Alzheimer's the cognitive portions of the brain are under attack from the get-go, in PPA it is the language center of the frontal temporal region that is under attack. In Mom's version of PPA cognitive function tends to remain normal. For info on this kind of thing I recommend visiting the Association of Frontotemporal Degeneration's website.

This means that over time Mom will lose the ability to use language - in any form. She will be trapped in her own head with limited means of communicating until language ceases to have meaning altogether. She already is struggling with spelling so writing out what she wants to say isn't very helpful. I did buy her an iPad with software recommended by a speech pathologist. A professional Mom refuses to go see again because an appointment costs $40. But that's yet another battle I am picking along at in an effort to get her training on how to use the software while she can still ask questions. I keep telling her I'll pay for the appointment to no avail.

The study is double blind - meaning not even the doctors know who is assigned the drug and who is assigned the placebo. It this study however there are two levels of the medication. A low dose (12 mg) and a higher one (40 mg) as well as the placebo. So Mom has a 2 in 3 chance (67%) of getting the medication instead of a 50/50 coin flip. The study is relatively large involving 1,960 people over 20 months. This month we have two appointments - tomorrow (the 9th) and the 21st. After that it goes down to one appointment per month and some of those are actually phone conferences.

Backing up a bit.... Mom's been having a rough time this last month. There are periods where things stabilize and then periods when things slide downhill. We are currently in a downhill slide. She had an appointment with her regular neurologist on Friday last. She can hardly get words out lately. He recommended a driving test as a baseline. He's concerned that if she is in an accident that is not her fault she will still be found at fault when it is known (and it will be) that she has PPA. If she has a document that says she's been tested and is safe to drive she'll be okay. 

She is, of course fighting this idea. So this is my new battle. It took six months to get he power of attorney paperwork, hopefully this won't also take six months.

Another example of the current battle.... I told her a month ago to keep her insurance card (Medicare) in her wallet. It was an argument but she complied. Now she can't find it BECAUSE SHE TOOK IT OUT OF THE WALLET and put it somewhere. So I have to go over there in the morning a couple of hours early to try to (a) find the card and/or (b) figure out who to call to get a new one. I don't even have any idea why she thinks she needs it... the study is 100% paid for by Merck. In fact, Merck is paying her $50 a visit to take part in the study. 

One upside in all this has been that even with all the testing we went through last year to get to a diagnosis Medicare has come through, there has been very little out of pocket expense for her.

Stay tuned. This is going to be a long, bumpy and extremely stressful ride.