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Alzheimer's Disease and Clinical Trials - Heroes Needed!

On the January 30th edition of Connelly Law’s Southcoast Seniors radio show, airing live every Thursday at 4:00 pm on WPRV 790am in Providence, the guest was Dr. John Stoukides, a renowned Alzheimer’s disease researcher and the Director of Geriatrics at Roger Williams Medical Center in Providence, RI as well as the medical director and lead researcher at Rhode Island Mood & Memory Research Institute (scroll to the end of this blog to hear the podcast).


Dr. John Stoukides, medical director and lead investigator at the Rhode Island Mood and Memory Research Institute

Dr. Stoukides discussed all things Alzheimer’s and focused on the importance of clinical trials when it comes to moving forward with research and treatment of this horrific disease.


So just how important are clinical trials? Dr. Stoukides succinctly summed it up like this, “without these, there can be no better treatments, no prevention and no cure for Alzheimer's disease.”


Let's explain further. Clinical trials are research studies conducted with volunteers to determine whether treatments are safe and effective. Without such research and the help of human volunteers, the hunt for a cure will stagnate. "We need volunteers," said Dr. Stoukides. "They are the unsung heroes of Alzheimer's research."


One of the questions asked about research concerned the terms "trials" and "studies". Do they mean the same thing? The answer is "it depends". Let's explain.


Although the terms can be used interchangeably, clinical trials and clinical studies mean essentially the same thing however, there are some subtle differences between the two depending on the circumstance. For instance, when testing drugs that prevent disease, that may be known as a "trial" while research involving volunteers receiving a certain type of intervention is referred to as a "study" because it involves studying the way people react. Clinical studies also look at other aspects in the care of people such as improving the quality of their life. Subtle -- but different.


In most cases, people tend to relate clinical studies to the testing of new medications, a requirement before any new medication related treatment is released for use -- and there are rules for this.

Before any new drug or treatment can be approved by the United States Food and Drug Administration (FDA), there is a clinical trial period. Below is a chart that shows the phases of such trials.


In the case of Alzheimer's and dementia studies, some focus on medication but there is a plethora of other research that does not. According to the Alzheimer's Association, when it comes to medication treatment trials involving the disease, these trials are basically divided into two categories that focus on:

  1. Reduction of Symptoms - During a trial like this, new drugs and the variations of existing drugs that are used to reduce the symptoms of Alzheimer's disease are tested. Existing drugs are studied around dosage, scheduled times of use, and drug combinations designed to reduce or delay the symptoms of the disease;

  2. Stopping the Disease - These trials focus on whether or not the medications are expected to slow or stop the disease. Some of the new drugs being tested represent new ways of treating Alzheimer's disease.


Then there are studies that are not solely medication-related, such as diagnostic studies. These studies explore finding better ways to diagnose Alzheimer's disease with the hope that the outcome will include a trusted and easy way to diagnose those people at risk for developing the disease even before the symptoms appear with the goal of stopping the development of dementia.


Participants in clinical trials of Alzheimer's research are necessary to keep moving forward in finding a way to battle this disease.

These types of studies are extremely important to the advancement of research methods because they identify which people to treat and can provide physicians with a way to track the effectiveness of treatment.


Other types of research include prevention trials where medical professionals seek ways to stop Alzheimer's from ever developing by using groups of volunteers who are pre-screened and considered to be at high risk of developing the disease. These studies focus on the use of certain medications, vitamins and even lifestyles that may prevent or lead to the onset of the disease.


Then there are quality of life studies where researchers try to better understand and address the needs that those with Alzheimer's have and attempt to find better ways to address the stress and emotional rollercoaster that caregivers and family members experience. The goal of these types of studies is to determine how much and what kind of support, education, and training is needed for those with the disease as well as for those caring for them.


Finally, online studies are gaining in popularity where the participants basically do all the work online and are not required to visit a particular site. This is important especially for those who live in rural areas where traveling to medical offices may be time-consuming and present as a hardship for those lacking resources such as transportation and respite needs.


As you can see, there are many kinds of studies that could be a fit for those who want to help find ways to conquer this disease from all angles. But, there is one huge obstacle in the way - a need for volunteers.


"We have a lack of participants," said Dr. Stoukides. "Yes, funding is a huge problem but even if we had all the money we needed, not having volunteers stands in the way of moving forward." The bottom line is this, researchers need volunteers with dementia, those who are caregivers, and healthy individuals to participate so that clinical trials can continue to move forward.


At the Rhode Island Mood and Memory Research Institute (RIMMRI), where Dr. Stoukides is the lead investigator and medical director, they have been involved in clinical research trials for the treatment and prevention of Alzheimer's disease for over twenty years. During this time, they have established an international reputation with the pharmaceutical industry as a leader in quality patient care, retention and data collection.


They have also participated in pivotal trials that have brought all the currently approved medications to treat Alzheimer's disease symptoms to the market. Today, RIMMRI is involved in cutting edge research to slow the progression of this disease in it's earliest stages.


The Safety of Clinical Trials

There may be some who want to volunteer but have concerns about safety. At RIMMRI, all clinical trials involving investigational treatments and medications are carefully supervised and evaluated for safety and effectiveness by a medical team. The FDA requires that all pharmaceutical companies thoroughly test new medications before they become available to consumers. All medications in use, be it prescription or over the counter, were first proven safe and effective in previous clinical trials.


And there is another benefit for volunteers. These studies offer participants, at no cost to them, free physical exams, study-related medical testing, study medications and an alternative to current treatments or therapies. And according to RIMMRI, many studies also offer compensation for time and travel.


Making The Decision

If a person decides to volunteer, the first step is meeting with healthcare providers to discuss any current health issues and treatment and to explore questions and concerns. At that point, the volunteer will be given informed consent (a process designed to give volunteers the information they need to decide about participating) to join the study. This process is designed to allow the volunteer to ask questions and exchange information with the clinical investigator. Health coverage is not required for participation.


Eligibility

As with all studies, there are certain eligibility guidelines for participants and some conditions that may disqualify a volunteer from being a part of this very important work. You may be eligible if you meet these criteria:


  • Be between the ages of 50 and 90

  • Experiencing a gradual change in memory

  • Diagnosed with mild Alzheimer's or Mild Cognitive Impairment

  • Have a friend, relative or caregiver willing to be your study partner.


The following are exclusionary criteria:


  • Having a pacemaker or any other metal in the body that would deny access to an MRI scan

  • History of seizures

  • Cancer within the past three years

  • Use of some blood thinners.


"Those who participate in clinical trials for Alzheimer's disease are really the heroes of our time," stressed Dr. Stoukides. "They may not only be helping themselves but will be paving the way to save the lives of those diagnosed in the future."


For those interested in being a volunteer, click on RIMMRI's logo below to go to their website or call them at 401-435-8950. They are located at 1018 Waterman Avenue, East Providence, Rhode Island.


NEXT WEEK'S BLOG: BRAIN SUPPLEMENTS - DO THEY PREVENT COGNITIVE DECLINE?



Click the photo above to learn more about Connelly Law's Safe Harbor Services for those diagnosed with dementia and those who love them.



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