Everything you need to know about participating in research
Two years ago, Joanne McGrath’s father sent her an article on dementia. The piece profiled University of Calgary researcher Dr. Marc Poulin and his study, “Brain in Motion I.” Its objective was to assess the effects of exercise on brain health, including cerebrovascular and cognitive functions with the help of research participants. At the time, McGrath’s mother was living with dementia, and her father was his wife’s primary caregiver.
McGrath clicked on a link at the bottom of the article, curious about participating in the study. For one, McGrath met the criteria: she was between the ages of 50 and 80, and, due to the diagnosis of a first-degree relative, she was at increased risk of developing dementia. Two, the study meant engaging in a more physically active lifestyle. Who wouldn’t benefit from becoming more physically active? And three, well, it was for a greater good.
“My mom has dementia, research is the key, so let’s sign up,” she thought.
It turned out the “Brain in Motion I” study was no longer recruiting active participants, but, one year later, the follow-up study, “Brain in Motion II,” began recruiting. McGrath volunteered, becoming a self-described “guinea pig” for dementia research.
What is a Clinical Trial?
Clinical trials are research studies that include human participants. In a clinical trial, which is one of the final stages of the research process, investigators introduce an intervention — an experimental medication, behaviour, or technology, for example — and examine its safety and effectiveness on humans with the help of volunteer participants. There are different types of trials. For example, some explore treatment and some explore prevention, such as a randomized controlled trial like “Brain in Motion.” All trials seek to establish therapies that cure, modify, prevent or manage the symptoms of any number of human disorders, from arthritis and asthma to cancer and Alzheimer’s disease and related dementias.
The type of intervention varies by study. Many people associate experimental drugs with clinical trials, but an intervention can also be a medical device, procedure, vaccine or non-pharmaceutical treatment such as education, technology, diet or exercise. A study out of the Université Laval and University of Alberta is examining the value of companion dogs and service dogs for people with mild to moderate dementia.
Clinical trials are key to identifying a cure or disease-modifying therapy for dementia. Dr. David Hogan is the academic lead of the Brenda Strafford Centre on Aging, and one of six members of a panel assembled by the Canadian Academy of Health Sciences to review the current state of knowledge about dementia and help in the development of a national strategy for Alzheimer’s disease and other dementias. The panel identified 44 key findings that require consideration in the effort to improve the quality of life and care of people living with dementia, including six dealing with research and innovation.
“Unless we do studies, we’re not going to develop better treatments and better ways of preventing the illness,” says Hogan.
According to ClinicalTrials.gov, a database of international privately and publicly funded clinical studies, there are approximately 80 active clinical trials in Canada studying new treatments for Alzheimer’s disease, specifically.
Clinical trials rely on human volunteers, but recruiting and retaining study participants can be a challenge. Researchers struggle with bridging the communication gap between the scientific community and the public, and, even when people are aware and willing, not all volunteers meet inclusion criteria or live near a study location. Low enrolment numbers can limit what researchers are able to interpret from the results.
Dementia research faces an even larger recruitment hurdle than other disorders. People living with dementia often need a caregiver to act as a study partner, and must have the capacity to consent themselves or provided legal authority to a caregiver. Alzheimer’s disease also has a slow, decades-long progression that is not well-understood, making it difficult for investigators to study interventions at the pre-symptomatic stage.
Making a Commitment
When Joanne McGrath was selected for the “Brain in Motion II” randomized controlled trial in 2018, there were eight other participants in her group. The study is examining an older population of people who are at an increased risk for Alzheimer’s disease and related dementias. Primarily, it seeks to understand how exercise improves brain blood flow and cognition, such as thinking, memory and reasoning skills.
Every Monday, Wednesday and Friday evening for six months, McGrath left her home in Cochrane, Alta., and drove to Calgary’s Shane Homes YMCA at Rocky Ridge for one hour of supervised exercise. Exercise, she emphasizes, not just activity. Participants had to maintain a percentage of heart-rate reserve, which is a percentage between resting heart rate and the maximal heart rate. The intensity was assessed using heart rate monitors.
McGrath and the other participants in her aerobic group were also expected to exercise at home once a week. Their output was tracked on a wearable heart rate monitor — McGrath dubbed hers “Jiminy Cricket.”
At the end of the six-month aerobic exercise period, none of the nine participants had dropped out. (The study continues to monitor participants for one year and aims to study 250-300 people.) Participants of a trial may leave at any time — they’re volunteers, after all — so McGrath was proud of her group of strangers-turned-“guinea pigs”-turned friends. She was also grateful for the accountability that a supervised exercise program provided, something she discovered she needed in order to prioritize her physical health. And contributing to research on dementia, something that affects her family and so many in Alberta, was the catalyst for it all.
“A lot of people are touched with dementia in their lifetime,” says McGrath. “It’s hard to find someone who’s not.”
Do Your Research
“We support and actually encourage people to be interested in clinical trials,” says Christene Gordon, provincial lead of client services and programs with the Alzheimer Society of Alberta and NWT. Gordon says, while they are not “active brokers” in connecting researchers with participants, the society does provide its client base with contact information of studies that are actively recruiting.
Gordon’s team also provides clients with a thorough checklist from the Alzheimer’s Society of Canada to help them make an informed decision. She says that clients often hear about experimental treatments or research from news coverage, but don’t know where to go from there. Gordon says potential volunteers shouldn’t be afraid to ask researchers questions. (See below.)
Clinical trials seek to establish whether a treatment is effective for humans or not — in the case of identifying a disease-modifying drug therapy for Alzheimer’s disease, it has more often been not. The very nature of this exercise can lead to disappointment for investigators, sponsors and participants.
Duncan McLean was diagnosed with early onset Alzheimer’s in 2017. His physician informed him of a worldwide clinical trial for an Alzheimer’s disease treatment, which, at the time, was seeking participants for its third and final phase before market. The treatment involved an antibody shown to remove beta-amyloid plaque from the brains of individuals with early Alzheimer’s disease. McLean was a good candidate for the trial and agreed to participate.
“Why wouldn’t I?” he says.
For about 17 months, McLean received monthly infusions, as well as his standard care. His commitment to the clinical trial included a series of MRIs, weight tracking and memory recall testing. McLean does not know if his infusions were the experimental treatment, or if he was part of the placebo group, but he did experience a relatively stable period throughout his participation.
“It wasn’t burdensome; I didn’t have any side-effects,” he says.
Disappointingly, the trial was cancelled after an independent data monitoring committee determined the trial was unlikely to meet its objectives. There was no risk to participants, its investigators made clear, but the interim results were not telling researchers to “keep going.”
“I went into it with my eyes open,” says McLean.
Although he was disappointed the trial was cancelled, and with it the momentum of the most promising drug Alzheimer’s research has had in years, McLean says he would still consider participating in another clinical trial in the future.
“If it’s something that makes sense, that fits my lifestyle and can be beneficial for others, I would look at it, for sure,” he says.
Idea to Impact
“The brain is the most complicated thing in the universe,” says Ty McKinney, research director for Calgary-based Branch Out Neurological Foundation. Branch Out has raised almost $3 million for alternative brain research, supporting studies that use innovative technology and non-pharmaceutical solutions like nutrition and physical activity to assess and manage disorders.
McKinney says there are short-term benefits to participating in and raising awareness of clinical research. For example, there is a strong body of research to suggest that exercise may lessen cognitive impairment and reduce dementia risk. While these studies continue to assess the why and the how, individuals can still add exercise to their lives as a potential disease-modifying behaviour.
Branch Out also seeks to accelerate the process from “idea to impact,” referring to the significant amount of time it can take an idea to go from a lab to demonstrating scientific merit to mainstream medical practice. This process can take a decade or more, and can feel overwhelming and far removed from the day-to-day life of someone living with dementia.
“Participating in research might sound kind of scary because it sounds like you’re being tested on in some capacity, but not all research has that sort of risk factor,” McKinney says. “In many ways, it can be positive, because people end up learning more about the disease and the brain itself, while directly contributing [to] the science that may end up developing a new treatment.”
Dispelling Myths Around Clinical Trials
Myth: “They don’t need participants.”
Recruiting and retaining volunteers for dementia research is a challenge. Studies are often in need of patient participants, healthy participants or both. Low enrolment numbers can limit researchers in interpreting the results.
Myth: “Tests are invasive and inconvenient.”
Testing can include surveys, cognitive tests and memory recall, fitness tests, brain mapping and imaging, and biomarker specimen analysis (blood, salvia samples, etc.) Researchers often strive to make it easier for participants to volunteer by accommodating flexible schedules or offering compensation for expenses such as travel and parking.
Myth: “There are too many risks.”
Risks vary by study, and it is up to each individual and their care team to weigh the potential benefits and risks before participating in a clinical trial. Using the checklist provided by the Alzheimer’s Society of Canada will help inform the process. [ ]