Charter Research is recruiting people at risk for Alzheimer’s disease to test whether a drug developed to slow the disease’s progression could be used for a new purpose—to potentially prevent Alzheimer’s altogether. If successful, the drug treatment would be a significant breakthrough in the fight against the dreaded malady.

“The thing that’s different about this trial compared to what people typically think about with research is it’s about prevention,” said Dr. Jeffrey Norton, medical director at Charter’s facility in The Villages. “The theory is that administration of this medication to somebody who’s been labeled at risk for Alzheimer’s disease could potentially prevent them from developing the disease.”

It Begins with a Blood Test

New, readily available blood tests can detect levels of certain beta-amyloid and p-tau proteins that are indicators of higher risk for Alzheimer’s disease. Individuals who have undergone such testing and were found to have higher levels of these proteins—but have no symptoms of dementia or Alzheimer’s—are ideal candidates for the trial.

“The truth is that our American healthcare system’s not terribly proactive, right? We wait for things to happen, and then we treat,” Norton said. “But the idea here is to try to get people to think in a different way. Is there something you could do before you get sick? If you have a strong family history, that’s something you should definitely not ignore.”

Could drug treatment help prevent Alzheimer’s?

Charter Research’s facilities in Orlando and The Villages are among more than 200 performing similar trials across the country. That includes administering the blood tests at either Charter location to potential trial candidates to determine their risk for Alzheimer’s, Norton said.

“Having that blood test, presuming you want to know the result, could be useful, too, because rather than wondering, ‘Am I going to have the same thing happen to me that happened to my parents?’ You could potentially act on it.”

Norton said he understands why some people might be reticent about taking the blood test. But inaction in this instance could be dangerous.

“What we’re trying to explain to people is that just because you feel well doesn’t mean you’re not at risk. It’s not to scare them, but just to say here’s some additional information,” he said, adding that the test is like women having annual mammograms to check for breast cancer or men having PSA tests to check for prostate cancer.

“It should be looked at as a potential preventative or risk assessment measure,” he said.

Potentially slow Alzheimer’s progression

Another thing for you to consider is that new drug treatments are being developed that could potentially slow or stop the ravages of the disease.

“Until very recently there were no drugs approved that had any impact on Alzheimer’s disease, and so the general thought process was, ‘This is a hopeless situation. So why should I care?’,” Norton said. “But that is no longer true. Now that we have treatments for people who have been diagnosed, you can say it’s like any other disease. The earlier you catch it, the less of a problem it could potentially be for you. Wouldn’t you rather find out when you’re either not sick at all or mildly affected?”

About the Trial

Candidates will undergo typical screening to ensure they meet criteria for participation. If chosen for the trial, you will undergo eight intravenous infusions of the drug over the course of eight months. The remainder of the trial will involve observation and periodic cognitive testing—over the course of a few years—that looks for signs of the disease’s progression.

“Anything that measures prevention of a disease has to be measured in years, not weeks or months,” Norton said.

The drug, donanemab, has been approved by the U.S. Food and Drug Administration (FDA) as a treatment for early-stage Alzheimer’s disease. The drug is delivered via infusion into the arm once a month and targets amyloid plaques. Clinical trials showed that donanemab slowed cognitive decline in people with early-stage Alzheimer’s disease over one year, including memory, thinking, and daily activities. It’s important to note, however, that this new trial tests the drug in people without Alzheimer’s (but who are at elevated risk of developing it). 

“What they’ve decided is that maybe you can take people who are at risk and see if you can prevent the disease,” Norton said. “So, it’s an entirely different model, but the same drug.”

Candidates for the trial can be those who already have been tested and shown to be at risk but are asymptomatic or healthy individuals who don’t have significant symptoms of memory loss and are willing to do the blood testing.

A New Potential for an Approved Drug

People considering participation can take comfort in knowing the drug has been through rigorous trials that show it provides some benefits and has been deemed safe.

“There are very infrequent side effects in the way in which the drug works on the brain.  While rare, those side effects can be severe in some cases, and that’s something that would be discussed in extreme detail with people who wanted to participate,” Norton said. “Generally speaking, the drug is very well tolerated and doesn’t have any permanent ill effects. I think that’s important for people to know, especially when they’re saying, ‘I feel fine. Why should I do this? And now you’re going to give me a medication that could be risky.’”

Norton concedes all treatments (including this one) have some risk, but added the benefits in this case could outweigh the risks.

“When it comes to prevention, it’s personality based,” he said. “Some people can’t tolerate that level of risk, but most people I think would say, ‘Well, I’d rather try something than wait for disaster.’”

The length of the trial could be a deterrent for some potential trial candidates but it shouldn’t be, Norton said. The infusions take approximately one hour per month over eight months.

Join the study today

“In other words, the length of the trial is not long because of the number of treatments, but because you have to observe people over a meaningful period of time. There would be much less frequent visits in the latter part of the study.

“Follow up visits would be a few times per year, and they could involve online cognitive assessment in some cases,” he said. “Most of our patients happen to live quite close to our facility. But if for some reason they didn’t, there’s a possibility that they could do them online.”

If you’re interested in learning more, fill out this form or give us a call at one of our research centers:

Orlando 407-337-3000
The Villages 352-775-1000