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Stanford Medicine begins enrolling for COVID-19 vaccine trial | News Center

Stanford Medicine has joined a large, Phase 3 clinical trial of an experimental vaccine against COVID-19.

The trial will test whether the vaccine, which is produced by the Janssen Pharmaceutical Companies of Johnson & Johnson, protects people from the disease. It will enroll some 60,000 people at about 180 sites around the world. The Stanford site is expected to enroll about 1,000 participants.  

Participants will receive either the vaccine or a placebo, and their health and immune responses will be monitored for about one year after their initial visits. If any participants become ill with symptoms of COVID-19, a health care provider will go to their homes to assess their health and collect a nasal sample to test for the presence of the novel coronavirus. If they are infected, Stanford physicians will monitor their disease progression. 

“We’re enrolling a wide variety of participants, but we are particularly interested in those who feel like their home or workplace exposure puts them at risk,” said Philip Grant, MD, assistant professor of medicine and the trial’s principal investigator at Stanford. “Teachers, grocery store workers, people who live in multigenerational households, health care workers and students on campus would all be good candidates for participation.”

Participants will be followed for two years and one month. They are expected to visit the trial site eight times: six in the first year and two in the second year. The initial visit will last about two hours; subsequent visits will consist of a short blood draw and symptom screening. If a participant develops COVID-19 during the study period, additional visits may be required.

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Regeneron stops enrolling critically ill COVID-19 patients for antibody drug trial

Regeneron Pharmaceuticals has paused enrollment of critically ill COVID-19 patients in its trial studying the antibody cocktail treatment that was given to President Trump earlier this month. The decision is due to potential safety concerns. 

The drug maker on Friday said it was suspending the enrollment of hospitalized COVID-19 patients requiring high-flow oxygen or mechanical ventilation after an independent monitoring committee observed “a potential safety signal and an unfavorable risk/benefit profile at this time.” 


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The enrollment of patients in this category will be on hold pending the collection and analysis of additional data. 

Trials will continue to test the antibody cocktail in hospitalized patients requiring little or no extra oxygen. Other trials involving mild or moderately ill patients can also move forward. 

The drug has shown encouraging results. Regeneron on Wednesday said early data showed the therapy reduced COVID-19 related medical visits by 57 percent. 

Regeneron earlier this month asked the Food and Drug Administration for emergency approval and said it would make doses available to the American people at no cost. The drug maker said it could have enough doses for 300,000 people in the coming months. 

On Monday, a study of Eli Lilly’s monoclonal antibody in hospitalized patients was stopped after it was found the treatment did not provide any benefit to COVID-19 patients. 

Earlier this month, Trump was given a single 8 gram dose of Regeneron’s experimental treatment under a compassionate-use request and credited the drug for helping him overcome the illness. 


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Keck Medicine of USC enrolling individuals in phase 3 clinical trial to treat mild Alzheimer’s disease using deep brain stimulation

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IMAGE: Darrin Lee, MD, PhD, a neurosurgeon with Keck Medicine of USC and the principal investigator of the site’s clinical trial
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Credit: Image courtesy of Ricardo Carrasco III of Keck Medicine of USC

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.

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Keck Medicine co-investigators of the trial include psychiatrist Carlos Manuel Figueroa, MD, and neurologist Elizabeth Joe, MD.

Deep brain stimulation has been

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