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Tests treatment safety and results for Psychosis Associated With Alzheimer's Disease
Official title A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
ClinicalTrials.gov ID: NCT05511363
What this study is testing
What is KarXT?
KarXT is an investigational medicine, being studied as a potential treatment for psychosis associated with alzheimer's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 90
You may be able to join if
- Is aged 55 to 90 years, inclusive, at Screening
- Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are...
- Meets clinical criteria for possible or probable Alzheimer's Disease
- Has a Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent...
- Living at the same location for a minimum of 4 weeks before Screening, with the intention of living at the same location throughout the study.
You likely can't join if
- Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia
- History of major depressive episode with psychotic features during the 12 months prior to Screening
- History of a diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
- Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic...
- Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of \<50 mL/min
- History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke
See the full eligibility criteria
Who can join
- Is aged 55 to 90 years, inclusive, at Screening
- Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the...
- Meets clinical criteria for possible or probable Alzheimer's Disease
- 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)...
- Living at the same location for a minimum of 4 weeks before Screening, with the intention of living at the same location throughout the study.
- Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified caregiver or study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant...
- History of psychotic symptoms (meeting International Psychogeriatric Association [IPA] criteria) for at least 2 months prior to Screening.
- Clinical Global Impressions-Severity (CGI-S) scale with a score ≥4 (moderate) at Screening and Baseline. CGI-S requires the assessor to consider aspects of the psychosis prior to providing a global assessment of...
- people are required to meet at least one of the following criteria at Screening and Baseline: i) Moderate to severe delusions, defined as Neuropsychiatric Inventory-Clinician (NPI-C): Delusions domain score of ≥2 on two...
- Mini-Mental State Examination (MMSE) score of 6 to 24, inclusive, at Screening
- 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 and be willing to maintain a stable dose for the duration of the study.
- 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
- BMI must be within 16 to 40 kg/m2 inclusive
- Female people 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...
What rules you out
- Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia
- History of major depressive episode with psychotic features during the 12 months prior to Screening
- History of a diagnosis 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...
- Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of \<50 mL/min
- History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke
- History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope
- Any of the following: i) New York Heart Association Class 2 congestive heart failure; ii) Grade 2 or greater angina pectoris; iii) Sustained ventricular tachycardia; iv) Ventricular fibrillation; v) Torsade de pointes...
- Myocardial infarction within the 6 months prior to Screening
- Personal or family history of symptoms of long QT syndrome as evaluated by the investigator
- Human immunodeficiency virus, cirrhosis, biliary duct abnormalities, active biliary disease, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history or liver function tests results
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the investigator
- Participants with any of the following: i) History of bladder stones; ii) History of recurrent urinary tract infections; iii) For male participants:
- Serum prostate specific antigen (PSA) \> 10 ng/mL at Screening
- An IPSS of 5 (almost always) on items 1, 3, 5, or 6
- A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9
- History of obstructive gastrointestinal disorder, gastric retention, irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months
- Risk of suicidal behavior during the study as determined by clinical assessment and/ or C-SSRS
- Clinically significant abnormal finding on the physical examination, electrocardiogram, or clinical laboratory results at Screening
- Urine toxicology screen is positive 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...
- Currently receiving monoamine oxidase inhibitors, anticonvulsants (e.g., lamotrigine, divalproex), mood stabilizers (eg, lithium) tricyclic antidepressants (e.g., imipramine, desipramine), or any other psychoactive...
- 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...
- Positive test for coronavirus (COVID-19) within 2 weeks before or at Screening; antigen or PCR local testing can be done at the discretion of the Investigator
- Unable to taper and discontinue a concomitant medication that would preclude participation in the study
- Prior exposure to KarXT
- Experienced any significant adverse events due to trospium, including a known hypersensitivity 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 past year
- Other protocol-defined Inclusion/Exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Homewood, Alabama, United States
- Phoenix, Arizona, United States
- Encino, California, United States
- Irvine, California, United States
- Orange, California, United States
- Pasadena, California, United States
- San Marcos, California, United States
- Walnut Creek, California, United States
- Colorado Springs, Colorado, United States
- Stamford, Connecticut, United States
- Boca Raton, Florida, United States
- Bonita Springs, Florida, United States
- Bradenton, Florida, United States
- Clermont, Florida, United States
- Daytona Beach, Florida, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Homestead, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
+ 78 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homewood, Alabama, United States; Phoenix, Arizona, United States; Encino, California, United States; Irvine, California, United States; Orange, California, United States; Pasadena, California, United States and 92 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.