A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years to 90 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well KarXT works and how safe it is compared with a placebo, a treatment with no active drug. It is for adults ages 55 to 90 with mild to severe Alzheimer's disease and moderate to severe psychosis, such as seeing things that are not there or having false beliefs.
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 55 to 90 years old and meet medical criteria for possible or probable Alzheimer's disease.
- Understand the study and its rules and give consent or agreement before any study tests.
- Have a brain MRI or CT scan from the past 5 years, taken after dementia began, to rule out other causes. If no scan is available, have one during screening.
- Have lived in the same home or assisted-living facility for at least 6 weeks before screening.
- Have a study partner with daily contact totaling about 10 hours a week or more.
- Have had psychosis symptoms, such as false beliefs or seeing things that are not there, for at least 2 months before screening.
- Meet required symptom scores at screening and the study's start: CGI-S of at least 4, and NPI-C of at least 6, with moderate to severe symptoms on at least 2 items for false beliefs or hallucinations.
- Score 8 to 22 on the MMSE, a test of memory and thinking, at screening.
Who can't join
- Have psychosis mainly caused by a condition other than Alzheimer's disease.
- Have had major depression with psychosis in the past 12 months, or a history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Have a serious health condition that the study doctor thinks could make participation unsafe, prevent completion of study steps, or affect the results.
- Have a history or high risk of trouble emptying the bladder or stomach, or narrow-angle glaucoma, an eye condition.
- Have taken KarXT before.
- Have had an allergic reaction to KarXT's inactive ingredients or trospium chloride, or a serious unwanted effect from trospium.
- Have received an experimental drug in another study within 3 months before screening, or joined more than 2 clinical studies in the past 12 months.
- Other study rules may also affect whether you can join.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Key Inclusion Criteria: 1. Is a male or female aged 55 to 90 years, inclusive, at Screening. 2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed. 3. Meets clinical criteria for Possible AD or Probable AD. 4. Must have 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. 6. Have an identified study partner who should have daily contact (approximately 10 hours a week or more). 7. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening. 8. CGI-S scale with a score ≥ 4 at Screening and Baseline. 9. AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline: 1. Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR 2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items 10. MMSE score of 8 to 22, inclusive, at Screening. Key Exclusion Criteria: 1. Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia. 2. History of major depressive episode with psychotic features during the 12 months prior to Screening. 3. History of bipolar disorder, schizophrenia, or schizoaffective disorder. 4. 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. 5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator. 6. Prior exposure to KarXT. 7. History of hypersensitivity to KarXT excipients or trospium chloride. 8. Experienced any significant adverse events (AEs) due to trospium. 9. 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 12 months prior to Screening. 10. Other protocol-defined inclusion/exclusion criteria may apply.
Study sites (70)
AZ
- Local Institution - 1116 · Chandler, AZ 85286More trials in Chandler
- Local Institution - 1044 · Phoenix, AZ 85012-2836More trials in Phoenix
CA
- Local Institution - 1104 · Anaheim, CA 92805-5854More trials in Anaheim
- Local Institution - 1119 · Canoga Park, CA 91303-1844More trials in Canoga Park
- Local Institution - 1151 · Encino, CA 91316More trials in Encino
- Local Institution - 1142 · Lancaster, CA 93534-2839More trials in Lancaster
- Local Institution - 1117 · Los Alamitos, CA 90720-6506More trials in Los Alamitos
- Local Institution - 1103 · Sherman Oaks, CA 91403-2131More trials in Sherman Oaks
- Local Institution - 1007 · Walnut Creek, CA 94596More trials in Walnut Creek
FL
- Local Institution - 1160 · Apopka, FL 32703-5835More trials in Apopka
- Local Institution - 1156 · Clermont, FL 34711-5190More trials in Clermont
- Local Institution - 1138 · Cutler Bay, FL 33189-1230More trials in Cutler Bay
- Local Institution - 1162 · Delray Beach, FL 33445-2581More trials in Delray Beach
- Local Institution - 1164 · Doral, FL 33122-1620More trials in Doral
- Local Institution - 1165 · Fort Myers, FL 33912-4302More trials in Fort Myers
- Local Institution - 1155 · Hialeah, FL 33012-3158More trials in Hialeah
- Local Institution - 1107 · Hialeah, FL 33012-3618More trials in Hialeah
- Local Institution - 1120 · Hialeah, FL 33012-4648More trials in Hialeah
- Local Institution - 1140 · Hialeah, FL 33016-1814More trials in Hialeah
- Local Institution - 0150 · Homestead, FL 33032-8187More trials in Homestead
- Local Institution - 1145 · Homestead, FL 33032-8187More trials in Homestead
- Local Institution - 1127 · Largo, FL 33777-1359More trials in Largo
- Local Institution - 1039 · Maitland, FL 32751-5669More trials in Maitland
- Local Institution - 1146 · Maitland, FL 32751-6138More trials in Maitland
- Local Institution - 1159 · Miami, FL 33032More trials in Miami
- Local Institution - 1118 · Miami, FL 33122-1721More trials in Miami
- Local Institution - 1111 · Miami, FL 33126-5683More trials in Miami
- Local Institution - 1108 · Miami, FL 33133-4231More trials in Miami
- Local Institution - 1125 · Miami, FL 33135-1601More trials in Miami
- Local Institution - 1115 · Miami, FL 33135More trials in Miami
- Local Institution - 1143 · Miami, FL 33145-2455More trials in Miami
- Local Institution - 1113 · Miami, FL 33155-6630More trials in Miami
- Local Institution - 1009 · Miami, FL 33155More trials in Miami
- Local Institution - 1129 · Miami, FL 33165-3947More trials in Miami
- Local Institution - 1150 · Miami, FL 33165More trials in Miami
- Local Institution - 1109 · Miami, FL 33174-2950More trials in Miami
- Local Institution - 1158 · Miami, FL 33175More trials in Miami
- Local Institution - 1147 · Miami, FL 33176-7947More trials in Miami
- Local Institution - 1105 · Miami, FL 33179-2537More trials in Miami
- Local Institution - 1157 · Miami, FL 33184-1412More trials in Miami
- Local Institution - 1126 · Miami Gardens, FL 33056-4000More trials in Miami Gardens
- Local Institution - 1102 · Miami Lakes, FL 33014-6435More trials in Miami Lakes
- Local Institution - 1136 · Orlando, FL 32806-1041More trials in Orlando
- Local Institution - 1112 · Orlando, FL 32807-3555More trials in Orlando
- Local Institution - 1137 · Port Orange, FL 32127-2914More trials in Port Orange
- Health Synergy Clinical Research,LLC - Stuart · Stuart, FL 34994Mohammad Nisar, Site 1101 · Study contact · 786-831-7303More trials in Stuart
- Local Institution - 1133 · Sweetwater, FL 33182More trials in Sweetwater
- Local Institution - 1041 · Tampa, FL 33607-4629More trials in Tampa
- Local Institution - 1124 · Tampa, FL 33614-2700More trials in Tampa
- Local Institution - 1123 · Tampa, FL 33614-2869More trials in Tampa
- Local Institution - 1110 · Tampa, FL 33629-5837More trials in Tampa
- Local Institution - 1040 · The Villages, FL 32159-8986More trials in The Villages
- Local Institution - 1131 · Viera, FL 32940Site 1131 · Study contactMore trials in Viera
GA
- Local Institution - 1152 · Augusta, GA 30912-0020More trials in Augusta
- Local Institution - 1141 · Columbus, GA 31909-1693More trials in Columbus
- Local Institution - 1161 · Decatur, GA 30030More trials in Decatur
IL
- Local Institution - 1148 · Elgin, IL 60123-9215More trials in Elgin
LA
- Local Institution - 1114 · Marrero, LA 70072-3083More trials in Marrero
MI
- Local Institution - 1139 · Rochester Hills, MI 48307-2760More trials in Rochester Hills
MS
- Local Institution - 1132 · Flowood, MS 39232More trials in Flowood
NV
- Local Institution - 1144 · Las Vegas, NV 89106-4145More trials in Las Vegas
NY
- Local Institution - 1153 · New Hyde Park, NY 11042-2062More trials in New Hyde Park
- Local Institution - 1135 · Port Jefferson Station, NY 11776-3386More trials in Port Jefferson Station
OH
- Local Institution - 1122 · Dayton, OH 45459-4248More trials in Dayton
PA
- Local Institution - 1149 · Malvern, PA 19355-3267More trials in Malvern
TX
- Local Institution - 1106 · Cypress, TX 77429-6070Site 1106 · Study contactMore trials in Cypress
- Local Institution - 1163 · Houston, TX 77074-2085More trials in Houston
- Local Institution - 1154 · Katy, TX 77450-1759More trials in Katy
- Local Institution - 1121 · Red Oak, TX 75154More trials in Red Oak
- Local Institution - 1134 · Stafford, TX 77477-3929More trials in Stafford