91制片厂 Hosts First U.S. Clinical Trial for Lewy Body Dementia
There are currently no medications available to specifically treat Lewy Body dementia (LBD). 91制片厂鈥檚 College of Medicine is spearheading the South Florida site for the first U.S. clinical trial for LBD.
The South Florida clinical trial is directed by one of the world鈥檚 leading neuroscientists and an expert on LBD, James E. Galvin, M.D., M.P.H., a professor of clinical biomedical science in 91制片厂鈥檚 College of Medicine, a professor in 91制片厂鈥檚 Christine E. Lynn College of Nursing, and medical director of 91制片厂鈥檚 Louis and Anne Green Memory and Wellness Center.
91制片厂鈥檚 Charles E. Schmidt College of Medicine is spearheading the South Florida site for the first U.S. clinical trial for Lewy body dementia (LBD), the second-most common dementia after Alzheimer鈥檚 disease. The HEADWAY-DLB is a phase 2b multi-center, double-blind, placebo-controlled study to evaluate an investigational medicine, RVT-101, for dementia with Lewy bodies. Currently, there are no medications available to specifically treat LBD, and patients are typically treated with medications for Alzheimer鈥檚.聽聽
The six-month study will enroll approximately 240 patients nationally to evaluate the safety and efficacy of RVT-101, a tablet that works by raising levels of acetylcholine, a vital chemical in the brain that helps with cognition and performing daily activities. Deficits in acetylcholine are a prominent feature of dementia with Lewy bodies. 聽聽
Because symptoms of LBD mimic other diseases like Parkinson鈥檚 and Alzheimer鈥檚, it is very difficult to diagnose often taking up to 18 months, with patients seeing a number of physicians over multiple visits. Patients, who are often misdiagnosed, are given medications for psychiatric disorders, Alzheimer鈥檚 and Parkinson鈥檚. The only way to confirm whether someone has LBD is with a post-mortem brain autopsy.
The late Robin Williams had this form of dementia as did legendary NHL coach Alger Joseph 鈥淩adar鈥 Arbour, legendary radio personality Casey Kasem, and most recently, Hall of Famer Gerald Eugene 鈥淛erry鈥 Sloane, former NBA player and head coach of the Utah Jazz.聽 聽
Dementia with Lewy bodies is a progressive type of dementia that affects more than 1 million people in the U.S. LBD is characterized by fluctuations in cognition, particularly in alertness and attention, and can make depression worse. Many LBD patients also have visual hallucinations and REM sleep behavior disorder. LBD is characterized by the buildup of abnormal protein clusters (known as 鈥淟ewy bodies鈥) within the brain.聽
The South Florida clinical trial is directed by one of the world鈥檚 leading neuroscientists and an expert on LBD, James E. Galvin, M.D., M.P.H., a professor of clinical biomedical science in 91制片厂鈥檚 College of Medicine, a professor in 91制片厂鈥檚 Christine E. Lynn College of Nursing, and medical director of 91制片厂鈥檚 Louis and Anne Green Memory and Wellness Center. 聽
Galvin developed the 鈥溾 (LBCRS) to quickly and effectively diagnose LBD and Parkinson鈥檚 disease dementia (PDD) in about three minutes. The LBCRS is a brief rating scale that can be completed by a clinician to assess clinical signs and symptoms highly associated with the pathology of this disease.
鈥淒iagnosing dementia with Lewy bodies early is critical, and with this important tool, a clinician can assess whether the patient has bradykinesia, rigidity, postural instability, or rest tremor without having to grade each extremity,鈥 said Galvin. 鈥淲e are hopeful that we also will be able to assist patients who have dementia with Lewy bodies with a medication that is designed to address their specific needs and condition.鈥 聽
Galvin has been working to improve clinical detections by combining biomarkers including high density EEG, functional and structural MRI, PET scans and CSF biomarkers to characterize and differentiate LBD from healthy aging and other neurodegenerative diseases. 聽
Galvin has led efforts to develop a number of dementia screening tools, including the (QDRS), AD8, a brief informant interview to translate research findings to community settings.聽 He has done cross-cultural validation of dementia screening methods in comparison with Gold Standard clinical evaluations and biomarker assays. His team also has developed sophisticated statistical models to explore transition points in clinical, cognitive, functional, behavioral and biological markers of disease in healthy aging, mild cognitive impairment, Alzheimer disease, and Parkinson鈥檚 disease.
Patients diagnosed with dementia with Lewy bodies can enroll in the study by contacting Katty Savaria, coordinator, at 561-356-4295.-91制片厂-
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