NCT06126224招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease
Karuna Therapeutics, Inc., a Bristol Myers Squibb company158 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年8月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 158
- 主要终点
- Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
研究概览
简要总结
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a male or female aged 55 to 90 years, inclusive, at Screening.
- •Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
- •Meets clinical criteria for Possible AD or Probable AD.
- •Must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening.
- •Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
- •Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
- •History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
- •CGI-S scale with a score ≥ 4 at Screening and Baseline.
- •AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline:
- •Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR
- •Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
- •MMSE score of 8 to 22, inclusive, at Screening.
排除标准
- •Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
- •History of major depressive episode with psychotic features during the 12 months prior to Screening.
- •History of bipolar disorder, schizophrenia, or schizoaffective disorder.
- •Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
- •History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
- •Prior exposure to KarXT.
- •History of hypersensitivity to KarXT excipients or trospium chloride.
- •Experienced any significant adverse events (AEs) due to trospium.
- •Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the 12 months prior to Screening.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo capsules
干预措施: Placebo (Drug)
KarXT
Experimental
Xanomeline and Trospium Chloride Capsules
干预措施: KarXT (Drug)
结局指标
主要结局
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
时间窗: Baseline and end of Treatment (up to 14 Weeks)
Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
次要结局
- Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) scale(Baseline and end of Treatment (up to 14 Weeks))
- Change From Baseline to end of Treatment in NPI-C Core score: Hallucinations, Delusions, Agitation, and Aggression Domains(Baseline and end of Treatment (up to 14 Weeks))
- Change From Baseline to end of Treatment in NPI-C: Agitation score(Baseline and end of Treatment (up to 14 Weeks))
- Change From Baseline to end of Treatment in NPI-C Core score: Caregiver Distress scale (Hallucinations, Delusions, Agitation, and Aggression domains)(Baseline and end of Treatment (up to 14 Weeks))
- Responder Rate(Baseline and end of Treatment (up to 14 Weeks))
研究者
研究点 (158)
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