Austin Research Site is One of Only 20 Globally Participating in Study
AUSTIN, TX – A new study to treat Alzheimer's disease is underway at Dell Medical School at The University of Texas at Austin, in partnership with Dell Seton Medical Center at The University of Texas. Dell Med is one of 20 sites in the United States and Europe selected to participate in the ADvance II Study, and it is the only site in Texas. The program is now screening for patients to participate in the study.
Initiated by Functional Neuromodulation, Ltd., ADvance II researches the use of a surgically implanted device that delivers mild electrical pulses to specific areas of the brain in people with Alzheimer’s. This deep brain stimulation (DBS) is given to the fornix, a place in the brain that plays a central role in memory. The ADvance II study is designed to evaluate the safety and efficacy of DBS of the fornix (DBS-f) for patients with mild Alzheimer’s disease.
Robert Buchanan, M.D., chief of neurosurgery at Seton Brain and Spine Institute and associate professor at Dell Med, is the study’s principal investigator. Robin Hilsabeck, Ph.D., director of the Comprehensive Memory Center, part of the Mulva Clinic for the Neurosciences at UT Health Austin, is the study's co-principal investigator. Hilsabeck and the Mulva Clinic’s cognitive disorders team perform pre-op screening and post-op evaluations of study participants. Buchanan will surgically implant the DBS-f device in the patients.
“We are honored to be selected as a study site for ADvance II,” said Buchanan. “Through Ascension Seton’s academic partnership with Dell Med and extensive experience with DBS surgery, we are hopeful that this study will be effective for this challenging and devastating disease.”
In this Phase III trial, study participants will have a DBS-f system implanted, with the stimulation device turned on for some participants and off for others. Those with the device left off at the start of the study will have it turned on after 12 months. All study participants will be regularly assessed for at least 48 months to measure their rate of Alzheimer’s progression. The DBS-f system or certain components of the system will likely remain in the body of study participants for the remainder of their lives.
Results from a feasibility study showed that DBS of the fornix may slow the rate of cognitive decline, compared to the expected rate of decline in mildly impaired people. It may also improve glucose metabolism in the brain associated with Alzheimer's.
“This is the pivotal trial phase of the study,” said Buchanan. “The first two phases showed that DBS-f could be applied safely in Alzheimer’s disease and promising evidence of efficacy, prompting the FDA to allow us to proceed with the Phase III trial.”
The ADvance II Study will initially involve about 210 people across all study sites who are greater than or equal to 65 years of age that have been diagnosed with mild Alzheimer’s disease. The research team from Dell Med is currently recruiting up to 20 eligible patients who meet additional criteria, including:
- Have a reliable informant who can attend all study visits and report on your daily activities and function
- Live at home and are likely to remain at home for the study duration
- Are on a stable doses of an FDA approved drug for Alzheimer's for at least two months, or have tried and failed
- Are in good health
- Complete an interview and standard screening tests
Study-related memory tests, physician exams and laboratory tests will be provided at no cost. Subjects will receive a stipend and be reimbursed for travel expenses associated with each study visit.
Patients who think they may be eligible for the ADvance II Study can visit mildalzheimersstudy.com or call 512-270-9039 to learn more.