NCT07011732招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 426
- 试验地点
- 157
- 主要终点
- Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.
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
- •- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.
- •ii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.
- •B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:
- •Amyloid PET.
- •Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
- •Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).
- •Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:
- •i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.
- •History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
- •AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
- •CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).
排除标准
- •- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
- •ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
- •iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
- •- Prior/Concomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).
- •A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.
- •B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).
- •C. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
- •- Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
KarXT + KarX-EC
Experimental
干预措施: Xanomeline/Trospium Chloride Capsule (Drug)
KarXT + KarX-EC
Experimental
干预措施: Xanomeline Enteric Capsule (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14
时间窗: At Week 14
Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14
时间窗: At Week 14
次要结局
- Change from baseline on the CMAI-IPA Domains at Week 14(At Week 14)
- Change from baseline on the CMAI Total Score at Week 14(At Week 14)
- Number of participants with vital sign abnormalities(Up to Week 18)
- Number of participants with suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to Week 18)
- Change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14(At Week 14)
- Number of participants with 12-lead electrocardiogram (ECG) abnormalities(Up to Week 14)
- Number of participants with AEs leading to study drug withdrawal(Up to Week 14)
- Barnes Akathisia Rating Scale (BARS)(Up to Week 14)
- Abnormal Involuntary Movement Scale (AIMS)(Up to Week 14)
- Body Weight(Up to Week 14)
- Body Mass Index (BMI)(Up to Week 14)
- Number of participants with clinical laboratory abnormalities(Up to Week 14)
- Severity of benign prostatic hyperplasia in male participants as assessed by International Prostate Symptom Score (IPSS)(Up to Week 14)
- Number of participants with Occurrence of Response at Week 14(At Week 14)
- Number of deaths(Up to Week 18)
- Change from baseline on the CMAI-IPA Domains at Week 14(At Week 14)
- Change from baseline on the CMAI Total Score at Week 14(At Week 14)
- Number of participants with Occurrence of Response at Week 14(At Week 14)
- Change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14(At Week 14)
- Change from baseline on the Neuropsychiatric Inventory/Neuropsychiatric Inventory -Nursing Home (NPI/NPI-NH) Total Score at Week 14(At Week 14)
- Number of participants with Adverse Events (AEs)(Up to Week 18)
- Number of participants with Treatment Emergent AEs (TEAEs)(Up to Week 18)
- Number of participants with Serious AEs (SAEs)(Up to Week 18)
- Number of participants with AEs of Special Interest (AESIs)(Up to Week 18)
- Abnormal Involuntary Movement Scale (AIMS)(Up to Week 18)
- Number of participants with vital sign abnormalities(Up to Week 18)
- Number of participants with clinical laboratory abnormalities(Up to Week 18)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Week 18)
- Number of participants with suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to Week 18)
- Severity of benign prostatic hyperplasia in male participants as assessed by International Prostate Symptom Score (IPSS)(Up to Week 18)
研究者
研究点 (157)
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