{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T17:21:57Z","timestamp":1778001717007,"version":"3.51.4"},"reference-count":27,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2024,3,5]],"date-time":"2024-03-05T00:00:00Z","timestamp":1709596800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAD"],"published-print":{"date-parts":[[2024,3,5]]},"abstract":"<jats:p>Background: Pimavanserin, a 5-HT2A receptor inverse agonist\/antagonist, is the only medication approved by the FDA for the treatment of hallucinations and delusions associated with Parkinson\u2019s disease psychosis (PDP). Further expanding knowledge of the safety profile of pimavanserin in PDP and neurodegenerative diseases (NDD) such as Alzheimer\u2019s disease is of great interest for informing its use in patients with PDP (with or without dementia), given this population is highly sensitive to adverse effects following antipsychotic use. Objective: This trial evaluated the effects of pimavanserin compared to placebo in frail older adults and elderly patients with neuropsychiatric symptoms related to NDD, such as hallucinations and delusions, to better understand the safety of pimavanserin in this population. Methods: This was a phase 3b, 8-week treatment (study duration of up to 16 weeks), multicenter, randomized, double-blind, placebo-controlled, two-arm parallel-group trial (NCT03575052). The primary endpoint was 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. Results: Incidences of TEAEs were similar between treatment groups; 29.8% reported \u22651 TEAE (pimavanserin: 30.4%; placebo: 29.3%), and 1.8% reported serious TEAEs (pimavanserin: 2.0%; placebo: 1.5%). Pimavanserin did not impact motor- or cognitive-related function. Conclusions: Pimavanserin was well tolerated and not associated with motor or cognitive impairment. Together, these findings highlight the manageable and generally favorable safety profile of pimavanserin in patients with NDD, contributing to our knowledge on the safety of pimavanserin as it generalizes to patients with PDP.<\/jats:p>","DOI":"10.3233\/jad-231167","type":"journal-article","created":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T11:15:42Z","timestamp":1709291742000},"page":"265-274","source":"Crossref","is-referenced-by-count":13,"title":["Safety Profile of Pimavanserin Therapy in Elderly Patients with Neurodegenerative Disease-Related Neuropsychiatric Symptoms: A Phase 3B Study"],"prefix":"10.1177","volume":"98","author":[{"given":"Gus","family":"Alva","sequence":"first","affiliation":[{"name":"Department of Psychiatry and Neuroscience, ATP Clinical Research, University of California at Riverside, Riverside, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wies\u0142aw J.","family":"Cuba\u0142a","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Faculty of Medicine, Medical University of Gda\u0144sk, Gda\u0144sk, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Berrio","sequence":"additional","affiliation":[{"name":"ACADIA Pharmaceuticals Inc., Princeton, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce","family":"Coate","sequence":"additional","affiliation":[{"name":"ACADIA Pharmaceuticals Inc., Princeton, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Victor","family":"Abler","sequence":"additional","affiliation":[{"name":"ACADIA Pharmaceuticals Inc., Princeton, NJ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanjeev","family":"Pathak","sequence":"additional","affiliation":[{"name":"ACADIA Pharmaceuticals Inc., Princeton, NJ, 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