By Ashley Benkarski
NASHVILLE, TN —Vanderbilt University’s AHEAD 3-45 Study team is seeking eligible participants for clinical trials of a drug that may offer a preventative solution to symptoms of Alzheimer’s Disease, and it couldn’t be at a more appropriate time; November is Alzheimer’s Awareness Month.
“Dementia is the overarching term for cognitive deterioration that is seen with various disorders. Alzheimer’s Disease is the most common cause of dementia,” explained Dr. Paul Newhouse, Director of the Center for Cognitive Medicine at Vanderbilt University Medical Center. He’s also the Clinical Core Director of Vanderbilt’s Alzheimer’s Disease Research Center.
Changes in the brain of those with Alzheimer’s can begin as soon as 20 years before the onset of symptoms. The AHEAD Study’s goal is to test whether early intervention can prevent future memory loss and dementia. “We are trying to find people who don’t have memory loss but do have one of the biological markers that suggest they are at high risk for developing Alzheimer’s later in life,” Dr. Newhouse said. “We’re trying to carry out the first major prevention trial, which is really pretty exciting.”
So, how do you know if you’re at risk for developing symptoms of Alzheimer’s? Dr. Newhouse said there are a few factors that get considered in the process of identification: a family history of early dementia (onset of symptoms before age 75), the presence of a certain variant of a genetic marker (Apolipoprotein E), and/or the presence of high levels of amyloids in the blood or the brain, which is suspected to be associated with elevated risk of developing symptoms.
The study focuses on these amyloids and whether reducing them will prevent symptoms from emerging. “The amyloid is maybe not the whole cause of Alzheimer’s Disease, but it is a spark that lights the fire,” Dr. Newhouse said. The idea is similar to introducing medicine to lower cholesterol to defend against developing heart disease.
There is no cost to the participant for any of the research, and the Center will provide the investigational treatment for free, as well as assist with transportation. And, though the course of the study runs four years, Dr. Newhouse stressed that people should know that participants aren’t guinea pigs— They can choose to leave the study at their will. But he also said people should know CCM will communicate information about the study and the treatment throughout its duration that’s important for people to know. “It’s very much a partnership between us as the research investigators and treating physicians and the patient,” he said.
“We screen them for having normal memory while also having one of the risk factors. If they do have a risk factor, we go ahead and get a scan of their brain, and if they have elevated levels of amyloids then we invite them to be in this treatment trial. Once they’re in the treatment trial, depending on how much amyloid is in their brain, they will come in for a once-a-month infusion of the treatment or twice a month,” Dr. Newhouse said. If the person already has memory loss, or if no amyloids are found, the person isn’t eligible to participate in the AHEAD Study but may be eligible for a more appropriate CCM treatment study.
“It’s very important for us to enroll a representative sample of what our community looks like,” he continued. “African Americans have been underrepresented in studies over the years. It’s a problem for the entire field of Alzheimer’s Disease research and we are committed nationwide to address this issue and to work harder to offer these kinds of studies to folks in our community that have not traditionally participated.”
According to a recent study, African-Americans as a whole tend to suffer higher rates of dementia, Dr. Newhouse said, though it’s unclear how much of a role Alzheimer’s Disease by itself plays in the onset of symptoms. Disproportionately higher rates of comorbidities such as diabetes may play a part in the emergence of dementia.
“One of the important facts that we know about Alzheimer’s Disease is that women are at higher risk. The reasons for this are complex and not fully understood,” Dr. Newhouse said. CCM has a Cognitive Health After Menopause (CHAMP) study to investigate which biological factors increase the risk for Alzheimer’s Disease in women. Post-menopausal women are encouraged to consider participating in that study.
“It’s not inevitable that you should lose your memory,” Dr. Newhouse said. “In fact, we think it’s abnormal to lose your memory. I remain more optimistic than I have ever been in my career that we are going to make major advances in the prevention and treatment of Alzheimer’s Disease.”
To enroll in the AHEAD clinical trials, call 1-800-AHEAD-70 or go to https://www.aheadstudy.org/pre-screener/.
For more information on open clinical trials visit Vanderbilt’s Center for Cognitive Medicine online at https://www.vumc.org/ccm/.