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Promising Alzheimer's research stalled by lack of volunteers for studies

"The focus today is mainly directed on early intervention," Dr. Ralph Richter says of current Alzheimer's research.

By
Brooks Hays
The combination of brain scan technology and an improved understanding of the biomarkers for Alzheimer's is slowly but surely enabling earlier detection and diagnosis of the neurodegenerative disease. But researchers say as a result, too much research is focused on prevention instead of treatment. Photo by Vava Vladimir Jovanovich/Shutterstock
The combination of brain scan technology and an improved understanding of the biomarkers for Alzheimer's is slowly but surely enabling earlier detection and diagnosis of the neurodegenerative disease. But researchers say as a result, too much research is focused on prevention instead of treatment. Photo by Vava Vladimir Jovanovich/Shutterstock

BOSTON, Feb. 10 (UPI) -- Researchers suggest that by 2020, the number of Americans living with Alzheimer's disease will have tripled, from about 5 to 15 million people. In the meantime, research into the best ways to prevent and treat the disease will continue.

But while promising new discoveries are made each year (and will likely continue to be made in the coming decades), doctors and scientists worry the pace of Alzheimer's research is too slow. They also worry the race for a cure may be a distraction from the pressing need to develop more effective treatments -- treatments that don't just stop Alzheimer's in its tracks, but also work to reverse the damage done.

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Part of the reason for both these problems, doctors say, is the dearth of Alzheimer's patients willing and ready to participate in various types of medical studies.

"It is in general a tremendous problem nationwide to recruit an adequate number of people to participate in Alzheimer's studies," says Dr. Robert Stern, clinical director at the Boston University Alzheimer's Disease Center.

Alzheimer's is a neurodegenerative disease responsible for more than 60 percent of all dementia. It's now the sixth leading cause of death in the United States. What normally begins as the slow arrival of minor memory loss issues -- often unnoticeable in its earliest stages -- soon begins to cascade, resulting in the loss of cognitive function and ultimately death.

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Though the exact origins are still being debated, scientists believe the accumulation of a plaque called amyloid and a protein known as tau play key roles in slowly disrupting neurological communication--corroding synapses, severing neural pathways and eventually killing brain cells. Technically, Alzheimer's can only be confirmed after death, by testing for the presence of amyloid and tau. But new ways to test for the biomarkers are showing progress, as are drugs that halt their growth.

These select few drugs, mostly called anti-amyloid drugs, are tremendously promising.

"The compound attaches to the bad amyloid and sucks it out of the brain," Dr. Stern says of one of the new drugs, still in Phase 2 trials. They're "truly modifying the disease course, and clinically you're preventing it."

But as Stern points out, these drugs will require early detection of the plaque and protein implicated in the onset of Alzheimer's. Today, most Alzheimer's cases aren't diagnosed until neuropsychological tests reveal varying mild cognitive impairment. And many diagnoses aren't made until dementia is knocking on the door. Even if anti-amyloid treatments make it to market, these new prevention treatments, Stern says, can only do so much for the more than 5 million Americans already living with the disease -- not to mention the "umpteen million more over the coming decades that are going to develop Alzheimer's disease," he says.

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Stern is a co-organizer of a nationwide study that is testing of one of the only drugs that shows promise for treating patients who are already battling Alzheimer's. The NOBLE Study, part of which is being organized and executed out of the Boston University Medical Center, features the drug T-817MA -- a compound that has (in test tubes and animal experiments) been shown to protect neurons against the toxicity induced by amyloid.

Even more importantly, Stern says, is that "it seems to also have an additional quality, which may promote the outgrowth of new connection between cells."

The T-817MA portion of the NOBLE Study is entering Phase 2, which means it has proven relatively safe and its early promise will now be tested on a larger group of patients.

But Stern says the progress is slow; and it's a problem he says isn't unique to his study. While he and other medical researchers are studying new experimental drugs, other scientists continue to search for the most effective way to recruit volunteers for Alzheimer's drug studies. Their work, too, has been slow to materialize results. Finding enough study participants remains one of the largest impediments to progress in Alzheimer's treatment research.

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"In my mind, it is a tragedy that we actually have so many exciting new drugs right now that are currently in clinical trials that provide so much possible hope," Stern said. "But it takes forever to get to the point of finishing the trial."

While the benefits of drug trials for Alzheimer's can be tremendous -- including access to new drugs, regular free healthcare consultation, and an influx of human connections while dealing with what can be a lonely disease -- doctors and researchers can understand why many are reluctant to volunteer.

Fear, shame and denial are all emotions that can influence patients facing a recent Alzheimer's diagnosis and the decision of whether to participate in a drug trial.

"There is a certain fearfulness of having an MRI or other diagnostic procedures performed," said Dr. Ralph Richter of Tulsa Clinical Research. "Others are hesitant having to stop taking medications that are exclusionary by the study protocol."

But regardless of their reasoning, Richter says it's up to the research team to build confidence, trust and rapport with recruits.

"Recognizing their concerns, being available to answer their many questions and being there for them and their family for support at all times, is what counts and makes patients decide to participate in a clinical research study," Richter says.

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And while more exhaustive but empathetic recruitment tactics may be a winning combination, there's still the ongoing discrepancy (funding and otherwise) between prevention and treatment research.

"The focus today is mainly directed on early intervention," Richter acknowledges. But finding a way to reverse the progression of Alzheimer's, he says, is essential.

"A large portion of the aging population has already been diagnosed with the disease."

For those and the many more who are expected to be diagnosed in the coming decades, T-817MA may be one of the few bright spots in treatment research. But its potential will only be realized if doctors like Richter and Stern can recruit enough volunteers to prove the drug's ready for Phase 3.

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