PDF(Pubmed)
Abstract：
UNASSIGNED: 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\'s disease psychosis (PDP). Further expanding knowledge of the safety profile of pimavanserin in PDP and neurodegenerative diseases (NDD) such as Alzheimer\'s 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Incidences of TEAEs were similar between treatment groups; 29.8% reported ≥1 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Incidences of TEAEs were similar between treatment groups; 29.8% reported ≥1 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.
UNASSIGNED: 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.
摘要：
■匹马万色林，5-HT2A受体反向激动剂/拮抗剂，是FDA批准用于治疗与帕金森病精神病（PDP）相关的幻觉和妄想的唯一药物。进一步扩大对pimavanserin在PDP和神经退行性疾病（NDD）（如阿尔茨海默病）中的安全性的认识，对于告知其在PDP（有或没有痴呆）患者中的使用非常有意义。鉴于该人群对使用抗精神病药物后的不良反应高度敏感.
该试验评估了匹马色林与安慰剂相比在虚弱的老年人和具有与NDD相关的神经精神症状的老年患者中的作用，比如幻觉和妄想,以更好地了解匹马色林在该人群中的安全性。
■这是一个3b阶段，8周治疗（研究持续时间长达16周），多中心，随机化，双盲,安慰剂对照,双臂平行组试验（NCT03575052）。主要终点是安全性和耐受性，通过治疗引起的不良事件（TEAE）进行测量。次要安全性终点是运动和认知功能的基线变化；探索性终点包括自杀，睡眠质量,神经精神症状.
■治疗组之间TEAE的发生率相似；报告≥1TEAE的比例为29.8％（吡马色林：30.4％；安慰剂：29.3％），1.8%的患者报告了严重的TEAE(吡马色林:2.0%;安慰剂:1.5%)。Pimavanserin不影响运动或认知相关功能。
■吡马色林的耐受性良好，与运动或认知障碍无关。一起,这些发现强调了匹马色林在NDD患者中的可管理且总体上有利的安全性，有助于我们对pimavanserin的安全性的认识，因为它推广到PDP患者。
该试验评估了匹马色林与安慰剂相比在虚弱的老年人和具有与NDD相关的神经精神症状的老年患者中的作用，比如幻觉和妄想,以更好地了解匹马色林在该人群中的安全性。
■这是一个3b阶段，8周治疗（研究持续时间长达16周），多中心，随机化，双盲,安慰剂对照,双臂平行组试验（NCT03575052）。主要终点是安全性和耐受性，通过治疗引起的不良事件（TEAE）进行测量。次要安全性终点是运动和认知功能的基线变化；探索性终点包括自杀，睡眠质量,神经精神症状.
■治疗组之间TEAE的发生率相似；报告≥1TEAE的比例为29.8％（吡马色林：30.4％；安慰剂：29.3％），1.8%的患者报告了严重的TEAE(吡马色林:2.0%;安慰剂:1.5%)。Pimavanserin不影响运动或认知相关功能。
■吡马色林的耐受性良好，与运动或认知障碍无关。一起,这些发现强调了匹马色林在NDD患者中的可管理且总体上有利的安全性，有助于我们对pimavanserin的安全性的认识，因为它推广到PDP患者。
