Author Interviews, Parkinson's / 25.07.2024
Pimavanserin Therapy in Elderly Patients with Neurodegenerative Disease-Related Neuropsychiatric Symptoms : Safety Study
MedicalResearch.com Interview with:
[caption id="attachment_62555" align="alignleft" width="200"]
Dr. Gus Alva[/caption]
Gus Alva, MD, DFAPA
Medical Director, ATP Clinical Research
Medical Director, Senior Brain Health, Hoag Hospital, Newport Beach,
Assistant Professor, Department of Psychiatry and Neuroscience
University of California, Riverside, CA
MedicalResearch.com: What is the background for this study?
Response: This trial evaluated the effects of pimavanserin compared to placebo in frail older adults and elderly patients with neuropsychiatric symptoms related to Neurodegenerative disorder (NDD), such as hallucinations and delusions, to better understand the safety of pimavanserin in this population.
The study was a phase 3b, 8-week treatment (study duration of up to 16 weeks) with the primary endpoint being safety and tolerability, measured by treatment-emergent adverse events (TEAEs). Secondary safety endpoints were change from baseline in motor and cognitive function; exploratory endpoints included suicidality, sleep quality, and neuropsychiatric symptoms.
The reason for doing this study is that there is a high degree of interest in further understanding the safety of pimavanserin, as many antipsychotics used off label often have significant and serious adverse effects, including risk of falls, parkinsonism, and death.
Dr. Gus Alva[/caption]
Gus Alva, MD, DFAPA
Medical Director, ATP Clinical Research
Medical Director, Senior Brain Health, Hoag Hospital, Newport Beach,
Assistant Professor, Department of Psychiatry and Neuroscience
University of California, Riverside, CA
MedicalResearch.com: What is the background for this study?
Response: This trial evaluated the effects of pimavanserin compared to placebo in frail older adults and elderly patients with neuropsychiatric symptoms related to Neurodegenerative disorder (NDD), such as hallucinations and delusions, to better understand the safety of pimavanserin in this population.
The study was a phase 3b, 8-week treatment (study duration of up to 16 weeks) with the primary endpoint being safety and tolerability, measured by treatment-emergent adverse events (TEAEs). Secondary safety endpoints were change from baseline in motor and cognitive function; exploratory endpoints included suicidality, sleep quality, and neuropsychiatric symptoms.
The reason for doing this study is that there is a high degree of interest in further understanding the safety of pimavanserin, as many antipsychotics used off label often have significant and serious adverse effects, including risk of falls, parkinsonism, and death.
Elena Stains
Medical Student
Department of Medical Education
Geisinger Commonwealth School of Medicine
Scranton, PA
MedicalResearch.com: What is the background for this study?
Response: Opioid use has been an increasing problem since the early 2000s in the United States (US) with a surge around 2010. Twenty-five percent of those having abused pain relievers in 2013 and 2014 got those drugs from physicians1. Physicians are particularly well-known for fueling the opioid crisis in Florida in the 2000s. Of the United States’ top 100 opioid prescribing physicians in 2010, an astounding 98 were prescribing in Florida2. Florida taking the main stage of the opioid crisis can be attributed to several factors, including ability of physicians to dispense opioids directly from their offices to patients (i.e. without pharmacists) and the presence of many infamous “pill mills” in the state3–6.
The researchers at Geisinger Commonwealth School of Medicine aimed to analyze the amount of hydrocodone (including brand names of Vicodin and Lortab) and oxycodone (OxyContin and Percocet) distributed in Florida from 2006 to 2021, paying close attention to the peak year of the opioid crisis, 2010. The team used the Washington Post and the US Drug Enforcement Administration’s Automation of Reports and Consolidated Orders System (ARCOS) databases to compile this compelling information.
Dr. Hagobian[/caption]
Todd Hagobian, Ph.D.
pronouns he/him/his
Department Chair & Professor, Kinesiology and Public Health
Cal Poly, San Luis Obispo, CA
MedicalResearch.com: What is the background for this study?
Response: Previous observational studies have shown that urinary BPA is related to Type 2 diabetes risk. Meaning, higher urinary BPA is related to an increased risk of Type 2 diabetes. However, no published study to date has determined whether several days of BPA administration (participants consume BPA) increases the risk of Type 2 diabetes.
MedicalResearch.com: Where is bisphenol found? Can exposure to bisphenol be limited in everyday life?
Response: BPA and other bisphenols are found in canned foods and plastics. BPA is one of the most widely used synthetic chemicals and we consume foods that are packed in this chemical. Most of BPA exposure comes from canned foods, and 93% of the US populations has detectable urine levels of BPA. We can limit BPA by reducing canned foods (or purchased BPA free cans) and plastic use.
Dr. LaMoreaux[/caption]
Brian LaMoreaux, MD, MS
Internist and Rheumatologist
Executive Medical Director, Amgen
MedicalResearch.com: What is the background for this study? How does KRYSTEXXA® (pegloticase) work in gout?
Response: Many other diseases in gout have well-defined definitions of remission, but gout has lagged behind on this. With systemic consequences of gout becoming more apparent, the concept of treating gout to remission is increasing important to improving patient care and preserving patient health.
Ben Petrazzini[/caption]
Ben Omega Petrazzini, B.Sc.
Associate Bioinformatician
Dr. Patel[/caption]
Rima Patel, MD
Assistant Professor, Division of Hematology/Oncology
The Tisch Cancer Institute
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: The 21-gene Oncotype DX Recurrence Score (RS) and 70-gene MammaPrint (MP) assays provide prognostic information for distant recurrence and are used to guide chemotherapy use in hormone receptor (HR)-positive, HER2-negative early breast cancer (EBC). Previous reports have demonstrated racial differences in the prognostic accuracy of the RS. In both the TAILORx and RxPONDER trials, Black women with low genomic risk (RS 0-25) had a higher recurrence risk than White women. In another study using the NCDB database,