A study to see how well KarXT is tolerated and how well tolerated it is when taken for long time in participants with psychosis associated with Alzheimer’s disease.
- Conditions
- Psychosis associated with Alzheimer’s DiseaseMedDRA version: 20.0Level: LLTClassification code: 10037234Term: Psychosis Class: 10037175MedDRA version: 20.0Level: PTClassification code: 10012271Term: Dementia Alzheimer's type Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-504151-27-00
- Lead Sponsor
- Karuna Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 349
1.Must have completed study KAR-031 or KAR-032, 2.Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent KAR-031 pr KAR-032 study, 3.Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are performed. If local regulations do not allow electronic IC forms, 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 (LAR) or study partner/caregiver, if local regulations allow, must provide IC (paper or electronic) b.The subject must provide informed electronic assent (paper or electronic), 4.At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject’s participation in the study., 5.Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified or proxy caregiver (spends approximately 10 hours/week with the subject) that 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 informed consent (paper or electronic) to participate in the study, 6.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). For the definition and list of highly effective methods of contraception, see full protocol/Appendix 1
1.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, 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.For males only, any one of the following: a.History of bladder stones; b.History of recurrent urinary tract infections; c.Serum prostate specific antigen (PSA) >10 ng/mL at Screening (Visit 1); d.An International Prostate Symptom Score (IPSS) 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 ideation and behavior during the study as determined by the Investigator’s clinical assessment and/ or C-SSRS at Visit 19 in study KAR-031 or KAR-032 as confirmed by the following: a.Answers Yes” on items 3, 4 or 5 (C-SSRS – ideation) ; b.Answers Yes” to any of the 5 items (C-SSRS behavior), 16.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, 17.Unable to taper and discontinue a concomitant medication that would preclude participation in this study, 2.Psychotic symptoms that are primarily attributable to a condition other than the AD causing dementia, e.g., schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features, 3.History of major depressive episode with psychotic features during the 12 months prior to Screening (Visit 1), 4.History of a diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, 5.Significant or severe renal impairment based on the opinion of the Investigator, 6.History of ischemic stroke within 12 months prior to Screening (Visit 1) or any evidence of hemorrhagic stroke, 7.History of cerebral amyloid angiopathy (CAA), epilepsy, central nervous system (CNS) neoplasm, unstable thyroid function, or unexplained syncope, 8.Any of the following: a.New York Heart Association (NYHA) 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 1)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method