Psychosis Associated With Alzheimer's Disease study: KarXT
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 to help prevent the return of psychosis symptoms in people with Alzheimer's disease. is designed to block specific brain receptors involved in causing hallucinations and delusions.
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 study aims to see if KarXT is better than a placebo at preventing the return of psychotic symptoms in people with Alzheimer's disease. It also looks at how safe and well-tolerated the drug is.
- Who it's for
- The study is looking for people who have Alzheimer's disease and are experiencing psychosis.
- What's involved
- Participants will take either KarXT or a placebo (a pill with no active medicine) and visit the clinic for check-ups and tests to monitor their health and symptoms.
- Time commitment
- The study lasts for 38 weeks and requires regular outpatient visits.
- 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.
- 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.
- 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.
- Participant is willing and able to attend the study visit for the study duration, follow instructions, and comply with the protocol requirements
- BMI must be within 16 to 40 kg/m2 and participants with a BMI of 16 to \<18 kg/m2 must have a body weight ≥40 kg.
- A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding.
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
- 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 is enrolling
- Orange, California, United States
- Walnut Creek, California, United States
- Clermont, Florida, United States
- Daytona Beach, Florida, United States
- Maitland, Florida, United States
- Tampa, Florida, United States
- Woodmere, New York, United States
- Houston, Texas, United States
- Pleven, Bulgaria
- Sofia, Bulgaria
- Zagreb, City of Zagreb, Croatia
- Prague, Praha, Hlavní Mesto, Czechia
- Pilsen, Czechia
- Rychnov nad Kněžnou, Czechia
- Reims, Marne, France
- Baggiovara, Modena, Italy
- Roma, Italy
- Belgrade, Belgrade, Serbia
- Belgrade, Serbia
- Kragujevac, Serbia
+ 11 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, but 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?
This study is enrolling now at Orange, California, United States; Walnut Creek, California, United States; Clermont, Florida, United States; Daytona Beach, Florida, United States; Maitland, Florida, United States; Tampa, Florida, United States and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.