SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the initiation of a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP). Of the more than 6.5 million people in the United States living with Alzheimer’s disease (AD), approximately 30% will experience psychosis, commonly consisting of hallucinations and delusions.1-3.

圣地亚哥-（商业线）-Acadia制药公司（纳斯达克股票代码：ACAD）今天宣布启动一项评估ACP-204治疗与阿尔茨海默病相关的幻觉和妄想疗效和安全性的2期研究精神病（ADP）。在美国患有阿尔茨海默病（AD）的650多万人中，大约30%会出现精神病，通常由幻觉和妄想组成。

The Phase 2 study is part of a seamless Phase 2 / Phase 3 program that includes three studies: a single Phase 2 study and two Phase 3 studies which have almost identical design. The Phase 2 study is a global, multi-center, randomized, double-blind, placebo-controlled trial that will enroll approximately 318 patients and evaluate ACP-204 30 mg and 60 mg doses compared to placebo.

第2阶段研究是无缝阶段2/阶段3计划的一部分，该计划包括三项研究：单一阶段2研究和两项具有几乎相同设计的阶段3研究。第二阶段研究是一项全球性，多中心，随机，双盲，安慰剂对照试验，与安慰剂相比，将招募约318名患者并评估ACP-204 30 mg和60 mg剂量。

The primary endpoint is change from Baseline in the Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions subscales (SAPS-H+D) total score at Week 6. The clinical trial sites will enroll seamlessly from Phase 2 into Phase 3. Each of the planned Phase 3 studies will enroll approximately 378 patients with ADP.

主要终点是第6周评估阳性症状-幻觉和妄想分量表（SAPS-H+D）总分的基线变化。临床试验点将从第二阶段无缝注册到第三阶段。每个计划的3期研究将招募约378名ADP患者。

Patients who complete the study will have the option of participating in a long-term open-label extension (OLE) study..

完成研究的患者可以选择参加长期开放标签扩展（OLE）研究。。

For more information about this study contact medicalinformation@acadia.com

有关此研究的更多信息，请联系medicalinformation@acadia.com

About Alzheimer’s Disease Psychosis

关于阿尔茨海默病精神病

According to the Alzheimer’s Association, more than 6.5 million people in the United States are living with Alzheimer’s disease (AD).1,2 Approximately 30% of patients with AD experience psychosis, commonly consisting of hallucinations and delusions.3 These symptoms may be frequent and severe and may recur over time.4 A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed, smelled) in nature.

根据阿尔茨海默病协会的统计，美国有650多万人患有阿尔茨海默病（AD）.1,2大约30%的AD患者患有精神病，通常由幻觉和妄想组成.3这些症状可能频繁且严重，并可能随着时间的推移而复发.4幻觉被定义为一种类似感知的体验，在没有外部刺激的情况下发生，并且是感官的（看到，听到，感觉，品尝，感觉，气味）。

A delusion is defined as a false, fixed belief despite evidence to the contrary. Serious consequences have been associated with psychosis in patients with dementia, such as increased likelihood of nursing home placement, more severe dementia, and increased risk of morbidity and mortality.5,6 There is no FDA-approved drug for the treatment of Alzheimer’s disease psychosis..

妄想被定义为一种错误的，固定的信念，尽管有相反的证据。严重后果与痴呆患者的精神病有关，例如养老院安置的可能性增加，痴呆更严重，发病率和死亡率增加.5,6没有FDA批准的药物用于治疗阿尔茨海默病精神病。。

About ACP-204

关于ACP-204

ACP-204 works primarily as an inverse agonist at the 5-HT2A receptor. ACP-204 is currently being developed for the treatment of Alzheimer's disease psychosis, for which there is a large unmet medical need and no FDA-approved medication.

ACP-204主要作为5-HT2A受体的反向激动剂起作用。目前正在开发ACP-204用于治疗阿尔茨海默病精神病，对此存在大量未满足的医疗需求并且没有FDA批准的药物。

About Acadia Pharmaceuticals

关于阿卡迪亚制药

Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapies for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome.

阿卡迪亚正在推进神经科学的突破，以提升生命。30年来，我们一直致力于医疗保健的前沿，为最需要他们的人提供重要的解决方案。我们开发并商业化了第一个也是唯一批准的用于与帕金森病精神病相关的幻觉和妄想以及用于治疗Rett综合征的疗法。

Our clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Prader-Willi syndrome, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia.com and follow us on LinkedIn and Twitter..

我们的临床阶段开发工作集中于治疗中枢神经系统疾病中精神分裂症，Prader-Willi综合征，阿尔茨海默病精神病和神经精神症状的阴性症状。欲了解更多信息，请访问我们的www.acadia.com，并在LinkedIn和Twitter上关注我们。。

Forward-Looking Statements

前瞻性声明

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties.

本新闻稿中并非严格具有历史意义的陈述是前瞻性陈述。这些陈述包括但不限于关于未来事件发生时间的陈述。这些陈述只是基于当前信息和期望的预测，涉及许多风险和不确定性。

Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia’s annual report on Form 10-K for the year ended December 31, 2022, as well as Acadia’s subsequent filings with the Securities and Exchange Commission.

由于各种因素，包括药物开发，批准和商业化固有的风险和不确定性，实际事件或结果可能与任何此类声明中预测的事件或结果有很大差异。有关这些因素和其他因素的讨论，请参阅截至2022年12月31日的Acadia 10-K年度报告，以及Acadia随后向证券交易委员会提交的报告。

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law..

警告您不要过分依赖这些前瞻性声明，这些声明仅在本声明发布之日起生效。这种谨慎是根据1995年“私人证券诉讼改革法”的安全港规定作出的。除法律规定外，所有前瞻性声明均受本警示性声明的整体约束，Acadia不承担修改或更新本新闻稿的义务，以反映本声明签署之日以后的事件或情况。。

References

工具书类

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1阿尔茨海默氏症协会。2023年阿尔茨海默病的事实和数字。阿尔茨海默氏症2023；19(4).

2 Rajan KB et al. Population estimate of people with clinical Alzheimer’s disease and mild cognitive impairment in the United States (2020-2060). Alzheimer’s and Dementia. 2021: 1-10.

2 Rajan KB等人。美国临床阿尔茨海默病和轻度认知障碍患者的人口估计（2020-2060）。阿尔茨海默氏症和痴呆症。2021: 1-10.

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3 Cummings J等人。主要和轻度神经认知障碍中的精神病标准：国际心理老年协会（IPA）共识临床和研究定义。老年精神病学杂志。2020; 28(12): 1256-1269.

4 Ballard C et al. A prospective study of psychotic symptoms in dementia sufferers: psychosis in dementia. Int Psychogeriatr. 1997; 9(1): 57-64.

4 Ballard C等人对痴呆患者精神病症状的前瞻性研究：痴呆症中的精神病。Int Psychogeriatr。1997; 9(1): 57-64.

5 Scarmeas N et al. Delusions and hallucinations are associated with worse outcome in Alzheimer Disease. Arch Neurol. 2005; 62(10): 1601-1608.

Scarmeas N等人。妄想和幻觉与阿尔茨海默病的恶化结果相关。Arch Neurol。2005; 62(10): 1601-1608.

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6 Peters ME等。神经精神症状作为严重阿尔茨海默氏痴呆和死亡进展的预测因子：Cache County痴呆进展研究。Am J精神病学。2015; 172(5): 460-465.