Phase 3 Alzheimer's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 55 to 90 years old at the time of screening.
• People who are able to understand what the study involves and sign a consent form — or, if they are not able to do this themselves, their legal representative can provide consent on their behalf, alongside the person's own agreement where possible.
• People who have been diagnosed with possible or probable Alzheimer's Disease.
• People who have had a brain scan (MRI or CT) within the past 5 years taken after dementia symptoms began, to rule out other brain conditions — or people who are willing to have one done during screening if no recent scan is available.
• People who have been living in the same place for at least 4 weeks before screening and plan to stay there throughout the study.
• People who can move around on their own or with a mobility aid, and who have a caregiver or support person who spends at least 10 hours per week with them and is willing to attend all study visits, help monitor medication and study procedures, and participate in study assessments.
• People who have been experiencing psychotic symptoms (such as hallucinations or delusions) for at least 2 months before screening, meeting specific international clinical criteria.
• People whose psychotic symptoms are rated as at least moderate in severity on a standard clinical scale at both screening and the start of the study.
• People who show moderate to severe delusions or moderate to severe hallucinations on a specific clinical assessment tool at both screening and the start of the study.
• People with a score of 6 to 24 on a standard memory and thinking test (called the Mini-Mental State Examination) at screening.
• People who are already taking Alzheimer's medications (cholinesterase inhibitors or memantine) and have been on a stable dose for at least 6 weeks before screening, and are willing to keep that dose stable throughout the study.
• People who are willing and able to attend outpatient clinic visits for the whole study and follow the study instructions.
• People with a body mass index (BMI) between 16 and 40.
• People who are not pregnant or breastfeeding, and — where pregnancy is possible — people who are willing to use at least one highly effective method of contraception during the study and for at least one menstrual cycle (approximately 30 days) after the last dose of study medication.

Who may not be able to join:

• People whose psychotic symptoms are mainly caused by a condition other than Alzheimer's Disease.
• People who have had a major depressive episode with psychotic features within the 12 months before screening.
• People who have a history of bipolar disorder, schizophrenia, or schizoaffective disorder.
• People with serious or severe medical conditions affecting the lungs, liver, kidneys, blood, digestive system, hormones, immune system, skin, nervous system, heart, or cancer — or any other condition that the trial doctor believes could affect safety or the ability to complete the study.
• People with significantly reduced kidney function, based on a specific kidney filtering test result falling below a set threshold.
• People who have had an ischemic stroke (a stroke caused by a blood clot) within the 12 months before screening, or any history of a bleeding stroke.
• People with a history of a specific type of blood vessel condition in the brain (cerebral amyloid angiopathy), epilepsy, brain tumours, unstable thyroid function, or unexplained fainting episodes.
• People with certain heart conditions, including a specific type of heart failure, moderate or greater chest pain (angina), certain dangerous heart rhythm problems, or who have an implantable cardiac defibrillator fitted.
• People who have had a heart attack within 6 months before screening.
• People with a personal or family history of a heart rhythm condition called long QT syndrome, as assessed by the trial doctor.
• People with HIV, cirrhosis, bile duct problems, active gallbladder or bile duct disease, liver or bile duct cancer, or active viral liver infections, based on medical history or liver test results.
• People with a history or high risk of difficulty passing urine (urinary retention), stomach emptying problems (gastric retention), or a specific type of increased eye pressure (narrow-angle glaucoma), as assessed by the trial doctor.
• People with a history of bladder stones or recurring urinary tract infections; and for male participants, certain prostate-related test results or urinary symptom scores above set thresholds at screening.
• People with a history of bowel blockage, stomach emptying problems, irritable bowel syndrome, or serious constipation requiring treatment within the last 6 months.
• People assessed as being at risk of suicidal behaviour during the study, based on clinical assessment or a standard safety scale.
• People with clinically significant abnormal results on a physical examination, heart tracing (ECG), or blood and urine tests at screening.
• People whose urine drug screen is positive for substances other than cannabis or certain short- or medium-acting sedatives (benzodiazepines), unless specifically approved by the study's medical monitor.
• People currently taking certain medications — including monoamine oxidase inhibitors, most anticonvulsants, mood stabilisers such as lithium, or tricyclic antidepressants — who are unable to complete a washout period before the study. Some antidepressants (such as SSRIs or SNRIs taken at a stable dose for at least 8 weeks, or mirtazapine or trazodone started at least 8 weeks before screening) may be permitted (confirm with trial site).
• People who the trial doctor or study sponsor considers unsuitable for the study for any reason, including concerns about safety or ability to follow the study schedule.
• People who have tested positive for COVID-19 within 2 weeks before or at the time of screening.
• People who are unable to stop taking a medication that would prevent participation in the study.
• People who have previously received the study drug KarXT.
• People who have previously had significant side effects or a known allergic reaction to a medication called trospium.
• People who have participated in another clinical trial involving an experimental drug within 3 months before screening, or who have taken part in more than 2 clinical trials in the past year.

Important: Always verify eligibility with the trial site directly before applying.