Dr. Dale Bredesen, one of the authors of the study published July 4 in the Journal of Alzheimer’s Disease, said this is the first clinical trial of its kind. Researchers followed 25 patients with mild cognitive impairment over nine months, looking at all the different contributors to cognitive decline. In the end, subjective scores showed 84% or 21 of 25 patients improved. GPB's Ellen Eldridge reports.
Rather than treating patients in clinical trials with a specific drug, doctors are taking a more personalized approach by attempting to understand root causes of and the best treatments for diseases affecting cognitive decline, such as Alzheimer’s.
Alzheimer's disease is a progressive neurodegenerative disorder that is characterized by cognitive decline and the presence of two core pathologies: amyloid β plaques and neurofibrillary tangles. Over the past decade, the presence of a sustained immune response in the brain has emerged as a third core pathology, according to the National Institutes of Health.
More than 130,000 Georgians of all ages are estimated to have Alzheimer’s disease or related dementia, according to the Georgia Department of Public Health.
With the growing percentage of Georgia aging population, DPH expects this number to increase to about 190,000 in the next decade.
That's an increase of about 46%.
The etiology of Alzheimer’s remains controversial — and that’s because many factors contribute to an individual’s chance of developing any disease of dementia.
Dr. Dale Bredesen, one of the authors of a study published July 4 in the Journal of Alzheimer’s Disease, said this is the first clinical trial of its kind. Researchers followed 25 patients with mild cognitive impairment for nine months, looking at many different contributors to cognitive decline. In the end, subjective scores showed 84% or 21 of 25 patients improved.
They did not treat patients blindly, Bredesen said.
“We look at over 150 different variables,” Bredesen said. “We look at genetics, we look at multiple biochemical pathways. We look to see what is driving this. Is this related to insulin resistance? Is it related to systemic inflammation, specific toxins, specific infections, vascular disease, sleep apnea, leaky gut, etc., etc.?”
While Bredesen’s clinical trial did not involve Emory University, Dr. Allan Levey, the neurologist leading Emory's personalized medicine efforts at the Goizueta Institute @ Emory Brain Health, has been gathering data about factors affecting dementia as well.
“Our approach to personalized medicine is with the recognition that there are these lifestyle factors like sleep, exercise and diet,” Levey said. “[Factors] like the degree of social interaction, [and] there are genetic factors, there's ancestry.”
Levey added that researchers can't study Alzheimer's without studying depression, without studying normal aging, without studying people who have had stroke, people who have ALS, and people with Parkinson's disease.
“So, we're taking a very broad approach where we get very similar measures on everybody so that we can then leverage the power of artificial intelligence to really understand, at an individual level, what's driving the disease in that person,” Levey said.
Bredesen and Levey agree that personalized medicine will be the wave of the future, similar to how cancer is being studied and treated.
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The small proof-of-concept clinical trial was wise to do, in Levey’s opinion, but he said this preliminary study, conducted without the appropriate scientific controls, is not conclusive.
“What they didn't do is reverse Alzheimer's disease,” Levey said, noting that mild cognitive impairment can either resolve on its own or develop into several diseases of dementia.
While not a causal relationship, Bredesen said researchers found an association between improving patients' metabolic factors and improvement of their cognition.
“If you look at the paper, there is a table that shows the improvements in the metabolic status,” Bredesen said. “So, for example, people improve their hemoglobin A1C, they improve their vitamin D levels, they improve their HS-CRP, which is a measure of systemic inflammation.”
The data helped determine proof-of-concept that a personalized medicine approach to Alzheimer’s disease and mild cognitive impairment deserves a larger, randomized, and controlled clinical trial, which is scheduled to begin recruiting in the next few months. This trial will also run for nine months at six sites: Miami, Florida; Cleveland, Ohio; Nashville, Tennessee; Sacramento and two sites in the San Francisco Bay area of California.
