Participants inclinicaltrials receive a high standard of care. At our center, our motto is, “whatever it takes,
however long it takes.” All participants have open access to our team of physicians, nurses, physician assistants, research coordinators, social workers, and psychologists. We are here to be a resource. We also work together with your primary care doctor to coordinate any changes in your treatment.
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 and oversight required to volunteers in clinical trials.
Alzheimer’s disease is the only top 10 cause of death in the U.S. without a way to prevent, cure or even slow its progression. A new treatment or cure for Alzheimer’s cannot be discovered without clinical trials, and many more participants are needed. At least 50,000 volunteers, both with and without Alzheimer’s, are urgently needed to participate. 80% of current trials are behind their enrollment goals. This makes a trial more expensive to conduct, as well as pushes back the timeline for a cure. The need for volunteers is more urgent than ever.
All FDA regulated studies in the United States require a double blind randomized placebo controlled study to be performed before a drug can be approved. This means that to begin with, the patient and the physician investigator do not know what drug they are receiving or what drug is being administered. However, in many trials, after a period of time, then all patients receive the study drug. This is called an “open label extension.” Entering a study must always be weighed against the natural history of the disease. In Alzheimer’s disease, the choices are simple. Alzheimer’s is a progressive terminal disease for which there is no cure and no significant disease-modifying treatments at this point. If one were to come in a clinical research trial and at least have a 50% chance of getting potentially a breakthrough medicine, this would be compared to not coming in a research trial in which that person would have 100% chance of not getting a breakthrough medicine. Doing nothing is not a good choice.
If one wanted to become part of a research study, they would need to sign an informed consent that discusses the risks, the benefits, as well as the nature and frequency of testing and procedures, and foremost, safety of the patient to be involved in a clinical research trial. There is no cost for research, which is underwritten by the pharmaceutical companies who are striving to get their drug approved, at which point they will make a significant profit. But in the interim, there are no costs. Therefore, whether one were to have good health care insurance, bad health care insurance, or no health care insurance at all, one could be considered a candidate for ongoing investigative trials.
A patient would never be involved in a study that offers no hope. Regarding the question about experimenting, and “laboratory animals,” the first thing every patient needs to know is that all study drugs have passed the animal phase and initial human phase of safety, and initial phase of evidence that there is efficacy for treating the disease.
Drugs that are currently being tested under the umbrella of the FDA are not experimental. These drugs have been studied and developed over years, sometimes decades with real expectations of both safety and benefit. Research studies represent a huge financial and intellectual investment by the pharmaceutical companies. They want the drugs to succeed, and they want you to succeed!
Essentially, only your time. There are no financial costs to you, and many benefits. You will be getting an opportunity to receive a potential new medicine that the drug company has spent many millions of dollars to bring to this current level of research, and may spend in any particlar Alzheimer’s trial up to five to six-hundred thousand dollars treating any one patient. In essence, the patient is a huge investment for them, and they want the patient to succeed.
There are Alzheimer’s clinical trials all over the country. It’s very common for subjects to need transportation assistance. At Brain Matters Research, we feel strongly that this shouldn’t be a barrier to volunteering for a trial. When you schedule your initial consultation, please indicate if you need assistance. We will work with you for that visit, as well as throughout your participation.
It’s very common for our trial volunteers to have other chronic conditions. However, they may still qualify for a clinical trial. Each trial has different, specific inclusion/exclusion criteria. If you don’t qualify for a specific trial, there will most likely be other alternatives. We are a large, specialized center that looks at several new trials every month.
There are clinical trials for every stage of Alzheimer’s. Participating in a trial could have a potentially measurable impact on the disease, the volunteer, as well as those future sufferers of Alzheimer’s.
By “cure” we mean complete reversal of the disease. This, unfortunately, is not possible. However, we are seeing some very positive results in many studies that we are currently performing, to decrease or even halt the progression of Alzheimer’s symptoms and stabilize mental, memory and cognitive functions. We do have some patients who have been stable (little disease progression for several years). They have not deteriorated!
Yes, it is most definitely a business, the most important business there is, the business of relieving pain, suffering, and disease, and it takes a lot of money to do it. The mission of Brain Matters Research is you and your loved ones, bringing you the most comprehension, current and ethical research and medical direction when needed to support you and your primary care physician and specialty doctors in the community. We do all of this as our business, “the business of hope.”