PER-001-24尚未招募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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Is a male or female aged 55 to 90 years, inclusive, at Screening (Visit 1A)
- •2. Can understand the nature of the trial and protocol requirements and provide
- •informed consent (IC) form before any study assessments are performed. If local regulations do not allow electronic IC form, then paper IC forms are permitted. If the subject is deemed not competent to provide IC, the following requirements for consent must be met:
- •a. The subject’s legally acceptable representative or study partner/caregiver, if local regulations allow must provide IC (paper or electronic)
- •b. The subject must provide informed assent (paper or electronic)
- •3. Meets clinical criteria for 1 of the following disorders:
- •- Possible AD or Probable AD (refer to Appendix 1 National Institute on Aging – Alzheimer’s Association Guidelines for All-cause Dementia and Alzheimer’s Disease)
- •4. Has 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
- •5. Living at the same home or residential assisted-living facility for a minimum
- •of 6 weeks before Screening (Visit 1A)
- •6. Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified study partner who should have daily contact (approximately 10 hours a week or more) and is willing to:
- •a. Attend all visits and report on subject’s status
- •b. Oversee subject compliance with medication and study procedures.
- •c. Participate in the study assessments and provide IC (paper or electronic) to participate in the study.
- •7. History of psychotic symptoms (meeting International Psychogeriatric
- •Association criteria) (Cummings 2020) for at least 2 months prior to
- •Screening (Visit 1A) (subjects may or may not have symptoms of agitation)
- •8. CGI-S scale with a score = 4 (moderate) at Screening (Visit 1A) and at Visit
- •2. CGI-S requires the assessor to consider aspects of the psychosis
- •(hallucinations and delusions) prior to providing a global assessment of
- •9. 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 (Visit 1A) and Visit 2:
- •a. Moderate to severe delusions, defined as NPI-C: Delusions domain score of = 2 on 2 of the 8 items OR
- •b. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of = 2 on 2 of the 7 items
排除标准
- •1. Psychotic symptoms that are primarily attributable to a condition other than
- •the AD causing the dementia, e.g., schizophrenia, schizoaffective disorder,
- •delusional disorder, or mood disorder with psychotic features
- •2. History of major depressive episode with psychotic features during the
- •12 months prior to Screening (Visit 1A)
- •3. History of bipolar disorder, schizophrenia, or schizoaffective disorder
- •4. 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
- •5. Significant and severe renal impairment based on a screening cutoff for
- •estimated glomerular filtration rate of = 60 mL/min/1.73 m2
- •6. History of ischemic stroke within 12 months prior to Screening (Visit 1A) or any evidence of hemorrhagic stroke
- •7. History of cerebral amyloid angiopathy, epilepsy, CNS neoplasm, unstable
- •thyroid function, or unexplained syncope
- •8. Any of the following:
- •a. New York Heart Association Class 2 congestive heart failure
- •b. Grade 2 or greater angina pectoris
- •c. Sustained ventricular tachycardia
- •d. Ventricular fibrillation
- •e. Torsade de pointes
- •f. Implantable cardiac defibrillator
- •9. Myocardial infarction within the 6 months prior to Screening (Visit 1A)
- •10. Personal or family history of symptoms of long QT syndrome as evaluated
- •by the Investigator
- •11. Human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities,
- •hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by
- •medical history or LFT results
- •12. History or high risk of urinary retention, gastric retention, or narrow-angle
- •glaucoma as evaluated by the Investigator
研究者
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