好色先生

好色先生

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Abstract Details

Antipsychotic efficacy and motor tolerability in a Phase III placebo-controlled study of pimavanserin in patients with Parkinson’s disease psychosis (ACP-103-020)
Movement Disorders
(-)
004
PDP is frequent, distressing and a leading cause of institutionalization. It also complicates PD management and has been linked to increased morbidity, incident dementia and mortality. Current antipsychotics lack efficacy and/or have considerable tolerability and safety concerns. Pimavanserin, a selective non-dopaminergic 5-HT2A receptor antagonist, has shown antipsychotic effects and good tolerability in previous Phase III trials, but a robust placebo effect precluded statistical separation.
Following 2-weeks screening, in which brief (non-pharmacological) psychosocial therapy adapted for PD (BPST-PD) was offered, 199 non-demented patients with moderate to severe psychosis (and on stable PD medication) were randomized to once-daily oral doses of 40mg pimavanserin or placebo (1:1) for 6 weeks.
Pimavanserin met the primary endpoint using SAPS-PD (a PD-adapted version of the Scale for Assessment of Positive Symptoms, assessed by independent raters): -5.79 PIM vs -2.73 PBO change from Baseline at Day 43 (LSM difference=-3.06; p=0.001). These results were supported by highly significant improvement in the secondary efficacy measure, CGI-Improvement (LSM difference -0.67; p=0.001), which was assessed by site investigators blinded to the SAPS-PD. Additionally, clinical benefits were observed in all exploratory efficacy measures with significant improvements in nighttime sleep, daytime wakefulness, and caregiver burden. Consistent with previous studies, pimavanserin met the key secondary endpoint for noninferiority to placebo on motor function (using UPDRS II+III) and was otherwise safe and well tolerated. The most common AEs were UTI (11.7% PBO, 13.5% PIM) and falls (8.5% PBO, 10.6% PIM). The only serious AEs that occurred in more than one patient were UTI (1-PBO, 3-PIM) and psychotic disorder (0-PBO, 2-PIM).
These data suggest that pimavanserin is effective, safe and well-tolerated for PDP. Utility in other neuropsychiatric disorders remains to be explored.
Authors/Disclosures
Jeffrey L. Cummings, MD, FAAN Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia, Actinogen, Acumen, AlphaCognition, ALZpath, Aprinoia, AriBio, Artery, Biogen, Biohaven, BioVie, BioXcel, Bristol-Myers Squib, Cassava, Cerecin, Diadem, Eisai, GAP Foundation, GemVax, Janssen, Jocasta, Karuna, Lighthouse, Lilly, Lundbeck, LSP/eqt, Mangrove Therapeutics, Merck, NervGen, New Amsterdam, Novo Nordisk, Oligomerix, ONO, Optoceutics, Otsuka, Oxford Brain Diagnostics, Prothena, ReMYND, Roche, Sage Therapeutics, Signant Health, Simcere, sinaptica, Suven, TrueBinding, Vaxxinity, and Wren pharmaceutical, assessment, and investment companies. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acadia, Biogen, Genentech, Grifols, Janssen, Karuna, Otsuka, reMYND, Roche, Signant Health. Dr. Cummings has stock in Artery, Vaxxinity, Behrens, Alzheon, MedAvante-Prophase, and Acumen. Dr. Cummings has received research support from NIH. Dr. Cummings has received research support from NIGMS. Dr. Cummings has received intellectual property interests from a discovery or technology relating to health care.
Roy E. Strowd III, MD, FAAN (Wake Forest School Of Medicine) Dr. Strowd has received personal compensation for serving as an employee of Kaplan. Dr. Strowd has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Monteris Medical, Inc. Dr. Strowd has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novocure. The institution of Dr. Strowd has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SpringWorks . Dr. Strowd has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for 好色先生. The institution of Dr. Strowd has received research support from Southeastern Brain Tumor Foundation. The institution of Dr. Strowd has received research support from Jazz Pharmaceuticals. The institution of Dr. Strowd has received research support from National Institutes of Health. The institution of Dr. Strowd has received research support from Alpha Omega Alpha. The institution of Dr. Strowd has received research support from American Board of Psychiatry and Neurology. Dr. Strowd has received publishing royalties from a publication relating to health care. Dr. Strowd has received publishing royalties from a publication relating to health care.
Stuart H. Isaacson, MD, FAAN (Parkinson's Dis & Mov Dis Ctr of Boca Raton) The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for acorda. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for adamas. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuroderm. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for adamas. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Roger G. Mills, MD No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Rohit Dhall, MD, FAAN (University of Arkansas for Medical Sciences) Dr. Dhall has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Best Doctors Inc. Dr. Dhall has stock in Verve Therapeutics Inc. Dr. Dhall has stock in Roche Holding Limited. Dr. Dhall has stock in Enliven Therapeutics Inc. The institution of Dr. Dhall has received research support from Amneal. The institution of Dr. Dhall has received research support from Neuroderm. The institution of Dr. Dhall has received research support from Cerevel Therapeutics. The institution of Dr. Dhall has received research support from Neurocrine. The institution of Dr. Dhall has received research support from Neuraly. The institution of Dr. Dhall has received research support from SPARC. The institution of Dr. Dhall has received research support from Pharma2B. The institution of Dr. Dhall has received research support from Alexion. The institution of Dr. Dhall has received research support from Parkinsons Foundation. The institution of Dr. Dhall has received research support from UCB Pharma. The institution of Dr. Dhall has received research support from Inhibikase Therapeutics. The institution of Dr. Dhall has received research support from Amylyx Pharma.
No disclosure on file