Clinical trials are essential to the success of research into Alzheimer's disease. Here's a discussion of five myths about clinical trials, from the Alzheimer's Association.
Myth 1: There are already plenty of volunteers. They don't need me to participate.
Fact: New treatments for Alzheimer's disease cannot be discovered without clinical trials, and many more participants are needed. Today, at least 50,000 volunteers, both with and without Alzheimer's, are urgently needed. More than 100 Alzheimer's clinical studies are now actively recruiting participants.
Myth 2: It's too late -- the disease is too advanced to participate in a research study.
Fact: There are clinical studies that work with people in every stage of Alzheimer's. Participating in a trial could have a potentially measurable impact on the disease.
Myth 3: Clinical trials are dangerous, because they use new and unproven methods and medications.
Fact: Clinical trials are experiments, and as a result there is always some level of risk involved. However, the ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most large clinical trials are federally regulated with built-in safeguards to protect the participants. That said, there may be unpleasant, serious or even life-threatening side effects to experimental treatment. Participants should discuss and understand any side effects with their doctor, and if necessary, they may withdraw at any time.
Myth 4: If I join a clinical trial, I won't receive the same quality of care that I currently have with my doctor.
Fact: Participants in clinical trials receive a high standard of care. Research shows that people involved in clinical studies do somewhat better than people in a similar stage of their disease who are not enrolled, regardless of whether the experimental treatment works. This may be due to the general high quality of care provided during clinical studies.
Myth 5: If I join a treatment clinical trial, I will get a placebo, and I don't want that.
Fact: In a randomized clinical trial, it is often the case that some participants get a placebo as part of the trial design. All potential participants should consider their comfort level in not knowing whether they will receive the experimental treatment or a placebo before deciding to join a trial. In some trials, people who receive the placebo first are guaranteed to get the trial treatment later.
Participating in clinical trials led us to very good care, and a referral to a specific NIH trial where the doc in charge was able to confirm what I suspected--that Jeff's specific form of AD was Posterior Cortical Atrophy. I stopped enrolling him when it seemed to be beyond his comprehension, what we were doing and why. So I guess that's my concern with Myth 2--it's never too late. I would say it's too late if the procedures and traveling would cause your LO too much distress or confusion.
Emily*, I agree that when it becomes difficult for your LO and they become distressed (because they don't understand, unfamiliar surroundings, etc.) then it is too late. Because all the clinical trials in our area were in major cities (at least 1.5 hours away), the noise, hubbub of city life, etc. and his tendency to wander, I decided not to enroll him in a trial. Every once in a while I feel guilty about it, like I didn't give him an opportunity to slow/improve his illness.
LFL, I don’t see any reason to feel guilty. Even if a study had found that a tested treatment was successful, your husband would have had at best a 50-50 chance of being assigned to the treatment group. And the cognitive testing your husband would have had to undergo as part of the study might have been demoralizing or upsetting to him. Just look at the comments on the thread that talks about what people’s spouses feel when they go to the neurologist.
As far as Myth #2 is concerned, I do not think that’s a myth, either. I’m not impressed by the claim that, “Participating in a trial could have a potentially measurable impact on the disease,” of a person with advanced AD. By “potentially measurable,” they mean the results could be statistically significant. That does not mean the treatment would make an actual difference in the life of the experimental subject.
My husband was one that refused doing a trial because he hated having the test they would do especially the memory. I had no intention of pushing it either.
Mary the biggest disappointment with a clinical trial was the one DW was in. It helped her. Regrettably it worked for only a small percentage of the test population. DW, who at the time had Moderate Stage - MMM scores of 16-18. Within 3 months of being on the experimental drug she achieved and maintained scores in the mid 20's for the remaining 12 months. The problem was even though this was a statistically significant change in her MMM scores only 12% of patients experienced this increase. The drug company concluded this was not a sufficiently positive result to make it worthwhile financially to make any attempt to bring this drug to market and even though very minimal side effects were reported. To make matter particularly painful they refused to make any of the drug available for "compassionate use" I conducted literally a heart breaking world wide search in an attempt to obtain this drug to no avail. The stress of the 2-4 hours of testing every four to six weeks mentioned by Charlotte was incredibly stressful.