CTIS2023-504416-16-00招募中1 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 (ADEPT-2) - KAR-032
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 811
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1.Is a male or female aged 55 to 90 years, inclusive, at Screening (Visit 1), 10. MMSE score of 8 to 22, inclusive, at Screening (Visit 1), 11.If the subject is taking a cholinesterase inhibitor and/or memantine, they must have been on a stable dose for 6 weeks prior to Screening (Visit 1) and willing to maintain a stable dose for the duration of the study, 12.Subject is willing and able to visit the clinic in an outpatient setting for the study duration, follow instructions, and comply with the protocol requirements, 13.BMI must be within 18 to 40 kg/m2 inclusive, 14.Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of IMP. Sperm donation is not allowed for 30 days after the final dose of the IMP. A female subject is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), 2.Can understand the nature of the trial and protocol requirements and provide informed consent (IC) before any study assessments are performed. 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 must provide IC b.The subject must provide informed assent, 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 1), 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 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 1) (subjects may or may not have symptoms of agitation), 8.CGI-S scale with a score = 4 (moderate) at Screening (Visit 1) 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 severity, 9.AD subjects are required to have NPI-C: H+D score of = 6 AND meet at least 1 of the following criteria at Screening (Visit 1) 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: Hallucin
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, 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, 13.Male subjects are excluded from the study if any of the following criteria apply: a.History of bladder stones b.History of recurrent urinary tract infections c.Serum prostate specific antigen > 10 ng/mL at Screening (Visit 1) d.An IPSS score of 5 (almost always) on items 1, 3, 5, or 6 e.A sum of scores on IPSS items 1, 3, 5, and 6 of = 9, 14.History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months, 15.Risk of suicidal behavior during the study as determined by the Investigator’s clinical assessment and/or C-SSRS as confirmed by the following: a.Answers Yes” on items 3, 4, or 5 (C-SSRS – ideation) with the most recent episode occurring within the 2 months before screening or, b.Answers Yes” to any of the 5 items (C-SSRS behavior) with an episode occurring within the 12 months before Screening, 16.Clinically significant abnormal finding on the physical examination, ECG, or clinical laboratory results at Screening (Visit 1), 17.Urine toxicology screen is positive for substances other than cannabis or benzodiazepines (both cannabis and short- or medium-acting benzodiazepines are allowed in limited quantities during the study) unless approval has been given by the Medical Monitor, 18.Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (e.g., lamotrigine, divalproex), mood stabilizers (e.g., lithium), tricyclic antidepressants (e.g., imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (e.g., 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.Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1), 19.If, in the opinion of the Investigator and/or Sponsor/Medical Monitor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator and/or Sponsor/Medical Monitor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements, 2.History of major depressive episode with psychotic features during the 12 months prior to Screening (Visit 1), 20. Known positive test for coronavirus disease 2019 (COVID-19) within 2 weeks before or at Screening (Visit 1); antigen or polymerase chain reaction local testing can be done at the discretion of the Investigator, 21.Unable to taper and discontinue a concomitant medication that would preclude participation in this study (e.g., cannot stop potent anticholinergic or antihistamine medication), 22.Prior exposure to KarXT, 23.History of hypersensitivity to KarXT excipients or trospium chloride, 24.Experienced any significant AEs du
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