The research nurse at Emory’s Brain Center called a week ago asking if we—Ralph and I because caregivers play an active role—would be interested in participating in a research study. The nurse had already looked at Ralph’s chart and said she thought he’d be a good fit.
The study is being conducted by the pharmaceutical company Merck on a possible treatment to slow the progression of Alzheimer’s. As the Merck brochure says, “This study is designed to test the idea that inhibiting a specific enzyme, BACE, may slow or stop the progression of Alzheimer’s disease. The drug in this study, MK-8931, is a BACE inhibitor, which means it helps stop the BACE enzyme from producing amyloid beta peptides. Amyloid plaque deposits in the brain may be the underlying cause of Alzheimer’s disease. By inhibiting the actions of the BACE enzyme, it may in turn help stop the formation of those amyloid plaque deposits.”
In other words, the study hopes to find a way to slow down the build up of the plaque that is assumed to cause Alzheimer’s and that is evident in Ralph’s brain according to the spinal tap his doctor administered several years ago.
I glanced at Ralph, who was on the couch having his afternoon nap, and said yes, I thought we might like to participate. I was actually quite excited. In the past Ralph has not qualified for studies and drug trials like this because of his MRI problem—the bb pellet that has been lodged in his tongue since a shooting accident when he was eight-years-old not only uncomfortably heats up during the procedure but distorts results—but this particular study has dropped the MRI requirement.
The nurse immediately emailed the study’s descriptions and consent forms, which I read and explained to Ralph. And explained again.
“I hate taking pills.”/“You won’t even notice the extra pill.”
“How often will I have to go see the doctor?”/“Every other month.”
“What if I’m stuck with the placebo? It’ll be a waste of time?”/“But the study will give you the real pill afterwards, and in any case, the study will benefit others, like your kids who are at genetic risk.”
“Ok, it sounds good. But I hate taking pills.” The familiar loop repeated itself over and over, and each time he ended up agreeing to participate, if with tepid enthusiasm.
Three days later we were at Emory. (Evidently the study, which has already been going for a year or two, needed a few extra last-minute entries and the deadline got pushed up so we were a rush job.)
Ralph took two memory/cognitive tests which have qualified him although “passing the test” is not the term I’d use exactly, at least not for the second test in which the cut off number had to do with having too much memory. Ralph evidently “passed” with flying colors because his memory score was very low. I have to say when the nurse whispered the news to me, my heart sank a little.
Now we are waiting for Merck to look at the scores before scheduling some physical tests. If Ralph makes it through through those, he will begin taking the extra pill with his Namenda and Donepezil daily. There is a one-third chance or receiving a placebo, a one-third chance of receiving a lowish dosage of the medication, and a one-third chance of receiving a higher dosage. I will be expected to keep track of his progress in some form that has not yet been clarified—I warned the research nurse that I may be travelling some in January after my daughter gives birth, but she said that would not be a problem.
Once Ralph starts the pill, we will meet every two months with medical personnel, including his neurologist, a dermatologist and the research nurse, for the next two years. When the two years are up, if he’s been taking a placebo, Ralph will then receive the higher dosage of the actual medication; otherwise he will continue on the dosage he started with.
I see no downside (except, if I am honest, the extra effort required on my part) and plenty of pluses. Because we are entering the study late, there is plenty of knowledge about side effects—minor and rare. The frequent visits to Emory are a great excuse to get Ralph out of the house and into the world. Plus he will be receiving more detailed health check ups on a more frequent basis. We will no doubt have a better sense of where he is on the continuum than we do now.
And, although he says he doesn’t care, the idea of doing something useful for others, of being part of a cause larger than himself, will give him a sense of purpose; even at Emory the other day I saw the shift from anxiety (which may have caused his low memory score) to energetic good cheer as he interacted with staff.
And if the medication makes a noticeable difference in Ralph’s condition, well that would be great too. Fingers crossed.
8 thoughts on “Ralph “Passes” the Test to Participate in Alzheimer’s Study”
Hi Alice – Good deal! I tried to enroll in a similar study (although it sounds similar enough that it might even be the same study) about a year ago, but “flunked” based on my neuropsych test results. As you say, there is no downside – some free medical care, some improvement if Ralph receives the real deal and it works, and a switch from the placebo later if the drug works. I’m sure that you will do more driving and record-keeping, though, and you’re already providing a lot of care. There will be a lot of people like me out there grateful your participation if the drug does work! Thanks, and good luck.
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Thanks….The good news for you is that you may have “flunked” because your memory and cognitive skills were too strong. If so, I hope this drug is approved in time to help you. I think it is one of the more promising trials out there, but that may be my wishful thinking.
This sounds very good, Alice. It is fortunate that you live near a clinical trial site and it’s great that you are willing to help Ralph participate.
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Thanks. We are lucky, not only to be near a clinical trial site but also a medical facility that has put so much emphasis on treating Alzheimer’s and cognitive issues. I can only imagine what it would be like to be without the specialized support Ralph and I receive. It is a major issue as I consider moving closer to other family in other states in the next few years.
I’ll cross my fingers, too. It sounds really interesting and positive in lots of ways, not least giving Ralph a chance to be out and about. I’m glad to hear there is little chance of side effects and the possibility it may slow down the progress of his cognitive impairment.
Intrigued about the BB pellet and Ralph’s accident – and about what happens during an MRI.
Thanks Mary. Am adding a post script in which I’ll describe the BB in more detail.
Oh Alice, this is so exciting. So happy for you and Ralph. We all need a little bit of hope.
You may have mentioned this in other posts; if so I apologize for asking. Did you notice an improvement after Ralph started the Namenda and Donepezil? My hubby has anosognosia, which is a fancy word for the fact that he has NO self perception of any of his deficits. It has made it incredibly difficult to get him any help. I’m in the process of changing his/our family doctor to a gerontologist. I’m holding out hope that she’ll give us some of the help that we desperately need.
Keep us posted on the research study. We all will be anxious to hear how he does. Ralph is so lucky to have you! 🙂
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Carole, the named and donepezil have have made a definite difference. When Ralph was first diagnosed, he was very resistant to acknowledging anything wrong and then very anxious. Once he started the drugs, there was an immediate change in what he called fuzziness–perhaps it was a placebo effect but who cares. He still does not acknowledge that he has more than a little problem with his memory but he can tell they help him stay less fuzzy. You definitely need to see a specialist. As I wrote above to Jabberwocky, I am lucky to be near (meaning an hour and half away) a medical facility with Alzheimer’s specialists. A Gerontologist should be able to help steer you and may provide a holistic approach that would be great. Good luck and keep me up to date on how your appointment goes