Can Stem Cells Address Behavioral Symptoms in Alzheimer’s Patients?
Summary
- A Miller School clinical study will test whether stem cell injections can reduce behavioral problems in Alzheimer’s patients by easing brain inflammation.
- Brain inflammation is an established part of the degenerative process in Alzheimer’s.
- Stem cells reduce inflammation, and Dr. Bernard Baumel will study their impact on behavior in Alzheimer’s disease patients.
As Alzheimer’s disease progresses, many patients develop severe behavioral problems such as agitation, aggression, abnormal sleep and sexual behaviors, hallucinations and delusions.
The symptoms can be overwhelmingly stressful for patients and their caregivers. But the existing options for behavioral treatment have dangerous side effects.
A clinical study beginning in May at the University of Miami Miller School of Medicine will test whether stem cell injections, which are far less risky, can reduce behavioral problems in Alzheimer’s patients by easing brain inflammation.
“I think that this study may help people, because it may show that the inflammatory response in the brain is an important abnormality to try to control,” said study leader Bernard Baumel, M.D., associate professor of neurology and director of memory disorders clinical trials at the Miller School.
Join the Clinical Trial
Learn more at ClinicalTrials.gov or email Dr. Bernard Baumel for more information.
The Goal of Reducing Inflammation
Alzheimer’s is the most common cause of dementia and affects more than 7 million Americans.
There have been slight improvements in treatment, Dr. Baumel said, but there are no treatments that stop or reverse Alzheimer’s progression. As the disease damages more areas of the brain, many patients begin having behavioral symptoms.
Antipsychotics can help, but these medications carry a “black box warning” from the FDA. They increase the incidence of stroke or death in older patients.
Brain inflammation is an established part of the degenerative process in Alzheimer’s. Studies have shown that consistent anti-inflammatory use throughout a person’s life is correlated with reduced Alzheimer’s risk, but starting anti-inflammatory medications after a person has the disease is ineffective, Dr. Baumel said.
But stem cells are also potent anti-inflammatories.
Dr. Baumel’s research team has been studying the potential for treating Alzheimer’s patients with stem cells for many years and has found the treatment can lead to some subtle improvements in mildly impaired patients. This new study will test the effects on behavioral symptoms specifically.
“The purpose is to see if injection of stem cells improves the behaviors and allows us to reduce or eliminate those dangerous medications the patients are taking,” Dr. Baumel said.
Potential for Symptom Improvement
For the study, Dr. Baumel will treat approximately eight patients with intravenous stem cells harvested from umbilical cords.
Dr. Baumel said these mesenchymal stem cells are used in treatments around the world, are hypoallergenic, don’t produce an immune response and have been shown to be safe by many researchers, including at the University of Miami’s Interdisciplinary Stem Cell Institute.
The research team will assess participants’ behaviors and measure whether they are able to reduce their antipsychotic medications.
“The real outcome will be reported to us by the caregiver — the spouse, child or somebody who’s around a lot that can report changes in behavior,” Dr. Baumel said.
The study will take 12 weeks, but Dr. Baumel hopes to see results within six. It’s important for patients experiencing these symptoms to improve as quickly as possible.
“Alzheimer’s disease starts very locally, and it spreads universally throughout the brain,” he said. “s”So we would expect, or hope, that the inflammation would be reduced or controlled.”
Every patient in the study will receive the stem cell treatment. If a significant number show improvement, Dr. Baumel plans to conduct a larger study with a placebo control.
Better Treatments for Alzheimer’s Disease
Dr. Baumel’s research is motivated by the essential need to find more effective treatments for Alzheimer’s.
When people lose control of their behaviors, their caregivers — who are often spouses who are also aging and have health problems of their own — are faced with a frightening problem, he said. This is compounded by the fact that patients with Alzheimer’s may now live a long time with their symptoms.
In addition to being stressful for individuals, the cost of treating Alzheimer’s is high and rising. According to the Alzheimer’s Association, Alzheimer’s and other dementias were estimated to cost the United States $360 billion in 2024, with the potential to rise to nearly $1 trillion by 2050.
“It’s a terrible, terrible social and medical problem that the country is dealing with,” Dr. Baumel said. “We’ve got to keep on trying.”
This research is supported by private donations and the Ohrstrom Foundation.
Tags: Alzheimer's disease, dementia, Department of Neurology, Dr. Bernard Baumel, mesenchymal stem cells, neurology, stem cells