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HYANNIS – Participants in a clinical trial of the experimental memory loss drug, aducanumab, expressed frustration earlier this year when the drug manufacturer Biogen suddenly announced it was discontinuing the trial, according to the Boston Globe.
Biogen’s explanation for stopping the clinical trial was that the drug was not effective, however the company in October reversed its decision after a new analysis of a larger dataset indicated that the drug was indeed effective at improving cognition, memory, orientation and language. Patients who were taking the drug were also better able to handle tasks of daily living better, according to Biogen.
Now, the manufacturer is asking the Food and Drug Administration to approve aducanumab for general use.
Navigating the journey of the drug over the least year reveals the ups and downs of drug trials. The Globe headline in March proclaimed, “For patients, Biogen news is an infusion of hope on Alzheimer’s.” But on the same day, a story ran in the New York Times with the headline, “That New Alzheimer’s Drug? Don’t Get Your Hopes Up Yet.”
Hyannis neurologist Sean Horrigan, DO, of Neurologists of Cape Cod, said both stories had elements of truth about the drug.
“Split the difference,” he said, meaning cautious hope is probably the best interpretation of the trials.
“I think it’s hopeful,” he said. “This study is a good reminder that there are aggressive measures in place to find a cure. I think what’s frustrating about not finding a cure is that it’s not for lack of trying. We’ve had so many drug failures over the past 20 years.”
The exact number of failed drugs is 146, Dr. Horrigan said, and there has not been a new drug for 19 years. There are currently only four approved drugs for the treatment of Alzheimer’s in the United States and none of them work very well, he said. At best, they improve symptoms and may slow disease progression.
Finding a More Radical Treatment
The problem with the current medications is that they are only designed to improve chemical communication amongst healthy nerve cells in the brain, he said. With Alzheimer’s, over the years you have fewer and fewer healthy nerve cells to reap the benefits of those medicines.
“With progression of dementia, you have more and more of these diseased cells, and so these drugs lose their effectiveness pretty quickly over time,” he said.
One of the reasons that Dr. Horrigan believes there have been so many drug failures is because researchers are trying to figure out a more radical way to treat the disease. Making more drugs to improve chemical communication isn’t the answer for a cure. Scientists are now trying to create a medication to prevent the characteristic and damaging plaque formation from happening in the first place.
“The working theory with Alzheimer’s disease is that you have these beta amyloid plaques and neurofibrillary tangles that start building up in number on the brain as the disease progresses,” he said. “Are these plaques and tangles causing Alzheimer’s symptoms or are they a byproduct of some other process? This question remains unanswered.”
Despite that uncertainty, all the recent research and clinical trials, like the one Biogen conducted, are aimed at creating a medication that will destroy plaque build-up and promote other anti-inflammatory therapies that can address the plaque building in the brain. Dr. Horrigan believes that the reason none of them have worked well is because they are being used too late in the disease to be effective.
Early detection is the key to addressing the disease because it can begin decades before the first symptoms show themselves, he said.
“If we’re trying the new experimental drugs out on 70- and 80-year-old people, once the disease shows itself, there is a lot of plaque buildup and tangle formation already in place,” he said. “We’re trying to put out a huge forest fire, but maybe what we need to do is utilize medications to put out the match starting the problem.”
Treatment on Cape Cod
As people age, the risk of developing cognitive issues increases. Because early detection is so important, the Neurologists of Cape Cod have been working closely with primary care doctors, other providers and the hospital to be more aggressive about screening for cognitive impairment. Their goal is for every patient 65 and older to have a mental status examination on an annual basis. If the patient has a family history of Alzheimer’s or dementia, test screening should begin at the age of 60.
The following three questions are a good screening tool, Dr. Horrigan said:
Are you managing your medications?
Are you managing your personal finances and balancing your checkbook and paying bills?
Are you driving well without any problems?
Some forgetfulness is perfectly natural as people age. Forgetting where you put your car keys or why you walked into a room isn’t cause for alarm. Forgetting how to get to your favorite coffee shop is, he said. When memory function starts to impact how you live on a day to day basis, that is a red flag that something more may be going on.
Realistically, Dr. Horrigan isn’t sure how successful scientists will be in finding a cure in the near future. He believes there is a better chance that researchers will develop a vaccine that prevents or halts the progress of the disease early on. But he points to the amazing advances and successes in HIV and cancer research as reason for hope that it’s only a matter of time before scientists have better treatment options for Alzheimer’s as well.
“The only way we’re going to find a cure is to get people involved with clinical research and participation in trials,” Dr. Horrigan said. “I have some patients who really want to be involved and do more to be part of the story to find a cure. I have a few patients enrolled with the Brigham and Women’s Hospital Alzheimer’s research department. They have four ongoing clinical research studies right now. These clinical trials involve medication that is similar in design to aducanumab.”