Keck Medicine of USC enrolling individuals in phase 3 clinical trial to treat mild Alzheimer’s disease using deep brain stimulation
LOS ANGELES — An estimated 5.5 million people in the United States live with Alzheimer’s disease, which is the most common form of dementia.
Keck Medicine of USC is enrolling individuals in an international phase 3 clinical trial to examine the safety and effectiveness of deep brain stimulation to treat Alzheimer’s. The study uses electrical impulses to stimulate the region of the brain known as the fornix, which is associated with memory and learning.
“Deep brain stimulation has successfully treated conditions such as Parkinson’s disease by improving motor skills, and we are now investigating if this therapy can stabilize or improve cognitive function,” says Darrin Lee, MD, PhD, a neurosurgeon with Keck Medicine of USC and the site’s principal investigator of the study. “Based on the results of earlier phases of this clinical trial, the treatment offers a potential benefit for patients with mild Alzheimer’s.”
This randomized, double-blind study will last four years. Subjects will first take a standardized assessment test for Alzheimer’s to be used as a baseline measure of cognitive ability throughout the study.
Next, researchers will implant electrodes into subjects’ brains that connect to a battery pack, similar to a heart pacemaker, placed underneath the collarbone.
For the first year of the study, subjects will be given either low-frequency stimulation to the brain, high-frequency stimulation or a placebo — no stimulation.
“For those with Alzheimer’s disease, certain parts of the brain become atrophied,” Lee says. “We are testing to see if stimulating the brain’s fornix can reawaken brain activity in this area and stop the progression of the disease.”
During the first year, subjects will be given subsequent cognitive tests to check if their memory or learning skills have held steady or improved. At the end of the year, study researchers will examine data to determine which level of stimulation had the most impact on these skills.
For the next three years of the trial, all subjects in the study will receive what researchers have determined is the optimal frequency of deep brain stimulation, even those originally receiving the placebo. Patients will continue to be given cognitive assessments throughout the four-year period.
To qualify for the trial, patients must be 65 or older, have been diagnosed with mild Alzheimer’s and take Alzheimer’s medication, and have a caregiver or family member who can accompany them to doctor visits.
The clinical trial involves approximately 200 patients at some 20 sites in the United States, Canada and Germany. Keck Medicine plans to enroll 8-15 patients.
The trial is sponsored by Functional Neuromodulation, Inc.
Those interested in enrolling in the clinical trial with Keck Medicine can contact Amanda Romano at [email protected] or 213-393-5640.
Keck Medicine co-investigators of the trial include psychiatrist Carlos Manuel Figueroa, MD, and neurologist Elizabeth Joe, MD.
Deep brain stimulation has been
D.C. gyms and fitness studios have been faced with a daunting realization: winter is coming. See how they are making changes, building workout pods, opening new facilities and also closing for good due to the coronavirus pandemic.
When the coronavirus pandemic swept across North America in March, it closed schools, businesses, restaurants and fitness centers, forcing many people to work from home and limit their mixing in society.
There was one silver lining: the weather, while brisk and blustery some of the time, was generally good, and getting better. It made exercising outside tolerable, and even appealing most days.
While many people continued their fitness programs over the last seven months with Zoom classes or dripping sweat on a treadmill or Peloton bike indoors, many moved outside.
Lured by good weather in the spring and fall, some people even survived the sultriest days by working out early in the morning or late in the evening.
But now, winter is coming.
What will fitness studios and gyms, many of which have moved workouts outside, do at the end of October as days get shorter and frigid mornings make it harder for clients to peel back the blankets and get out of bed?
For the owners of four D.C. independent fitness studios, there are four distinct choices: invest in a new studio that supports a hybrid indoor/outdoor workout; encourage athletes to come back indoors while working out in masks and maintaining their distance; build individual workout “pods” separated by a frame and plastic sheeting; or, sadly, decide to shut down for good.
For Chris and Alex Perrin, the husband and wife team who own Cut Seven, a facility that offers an intense, boot-camp style workout in Logan Circle, the pandemic put on hold expansion plans, moved classes outside onto a D.C. school’s soccer field, and
A 20-year-old Colorado resident who battled the novel coronavirus later developed a rare but serious condition known as multisystem inflammatory syndrome (MIS-C), according to local health officials in the state.
The resident, of Boulder County, suffered only mild symptoms of COVID-19 and “appeared to have fully recovered,” said county officials in a news release. But three weeks later, the resident fell ill once more — this time with “severe abdominal pain, watery diarrhea, and fever,” all of which are signs of MIS-C.
Since the pandemic began, there have been various reports of multisystem inflammatory syndrome, but most cases have occurred in children, which is known as MIS-C.
The syndrome is an inflammatory condition that is similar to Kawasaki disease, which causes swelling in arteries throughout the body. Many children with MIS-C — which causes inflammation in the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs — have either been infected with the novel coronavirus or had been exposed to someone with a COVID-19 infection, health officials have sad. MIS-C can also cause persistent fever, rashes, vomiting and diarrhea, among other symptoms such as a red tongue and eyes.
LOUISIANA CHILD’S POSSIBLE CORONAVIRUS-LINKED MIS-C DEATH THE FIRST IN STATE
However, earlier this month, the Centers for Disease Control and Prevention (CDC) identified the condition among adults, drawing on reports of 27 adult patients to describe a new, similar condition known as multisystem inflammatory syndrome in adults (MIS-A).
“Findings indicate that adult patients of all ages with current or previous SARS-CoV-2 infection can develop a hyperinflammatory syndrome resembling MIS-C,” the authors wrote at the time, adding that measures to limit COVID-19 spread may help prevent MIS-A.
SERIOUS CORONAVIRUS-RELATED INFLAMMATORY CONDITION AMONG CHILDREN NOW REPORTED IN ADULTS: CDC
The Colorado patient required hospitalization and intensive care before they improved and were eventually discharged from the hospital. However, “while most young adults experience mild symptoms from COVID-19,” officials warned, “this case is an example of how the disease can progress and how little is known about the long-term impacts of the illness.”
RARE CORONAVIRUS-LINKED SYNDROME AFFECTS 11 CHILDREN IN WASHINGTON STATE: OFFICIALS
“I hope sharing the information about this patient’s experience will help others to better understand how serious COVID-19 can be, even for young people,” said Dr. Heather Pujet, an infectious disease doctor at Boulder Community Health, in a statement. “The patient became extremely ill very quickly with multi-organ system involvement; they fortunately recovered after a period of severe illness. However, this should serve as a warning for the younger people in the community to please not disregard their own personal risks with COVID-19.”
“Much remains unknown about how this condition develops, but it’s related to the body’s attempts to fight an invader,” added Dr. Sam Dominguez, a pediatric infectious disease specialist at Children’s