A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
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 safe KarXT is and how well it works for psychosis linked to Alzheimer's disease. 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.
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
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 at the first screening visit.
- Have Alzheimer's disease diagnosed using the 2024 Alzheimer's Association guidelines.
- Have a brain MRI or CT scan from the past 5 years, taken when dementia began or later. The scan must rule out other brain diseases that could explain the dementia.
- Have psychosis symptoms that meet the study's guidelines for at least 2 months before screening. Agitation may or may not be present.
Who can't join
- Have psychosis mainly caused by a condition other than Alzheimer's disease.
- Have had major depression with psychosis in the 12 months before screening.
- Have a history of bipolar disorder, schizophrenia, or schizoaffective disorder, which involves both psychosis and mood symptoms.
- Have certain safety concerns, including some abnormal lab test results.
- Other study rules may also affect who can join.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria * Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). * Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * Patient 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, eg, major stroke, neoplasm, subdural hematoma. * Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation). Exclusion Criteria \- Patients will not be able to participate if they have: i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features. ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities. \* Other protocol-defined Inclusion/Exclusion criteria apply.
Study sites (102)
AZ
- Local Institution - 1227 · Chandler, AZ 85224More trials in Chandler
- Gilbert Neurology Partners - PLLC - Avacare · Gilbert, AZ 85297Jonathan Hodgson, Site 1247 · Study contact · 602-761-9631More trials in Gilbert
- Banner Alzheimer's Institute · Phoenix, AZ 85006-2528Ganesh Gopalakrishna, Site 1217 · Study contact · 602-839-6900More trials in Phoenix
- Local Institution - 1220 · Scottsdale, AZ 85260-6742More trials in Scottsdale
CA
- Advanced Research Center, Inc. · Anaheim, CA 92805-5854Steven Macina, Site 1104 · Study contact · 714-999-6688More trials in Anaheim
- Inland Psychiatric Medical Group (IPMG)-Chino · Chino, CA 91710Nandita Puchakayala, Site 1244 · Study contact · 909-488-9116More trials in Chino
- Local Institution - 1230 · Long Beach, CA 90805More trials in Long Beach
- USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) · Los Angeles, CA 90033-5313Lon Schneider, Site 1226 · Study contact · 323-442-3715More trials in Los Angeles
- Local Institution - 1219 · Los Angeles, CA 90095More trials in Los Angeles
- Local Institution - 1001 · Orange, CA 92866More trials in Orange
- Local Institution - 1228 · Orange, CA 92868-2847More trials in Orange
- Local Institution - 1043 · Pasadena, CA 91106More trials in Pasadena
- Local Institution - 1213 · Rancho Cucamonga, CA 91730More trials in Rancho Cucamonga
CT
- University of Connecticut Health Center · Farmington, CT 06030Neha Jain, Site 1222 · Study contact · 860-790-7354More trials in Farmington
FL
- Local Institution - 1225 · Atlantis, FL 33462More trials in Atlantis
- Envision Trials LLC · Bonita Springs, FL 34134Daniel Mandri, Site 1020 · Study contact · 305-819-2909More trials in Bonita Springs
- Local Institution - 1138 · Cutler Bay, FL 33189-1230More trials in Cutler Bay
- Arrow Clinical Trials · Daytona Beach, FL 32117-5532David Billmeier, Site 1023 · Study contact · 386-278-8000More trials in Daytona Beach
- Local Institution - 1224 · Deerfield Beach, FL 33442More trials in Deerfield Beach
- Local Institution - 1164 · Doral, FL 33122-1620More trials in Doral
- Local Institution - 1264 · Gulf Breeze, FL 32561Site 1264 · Study contactMore trials in Gulf Breeze
- Local Institution - 1120 · Hialeah, FL 33012-4648More trials in Hialeah
- Local Institution - 1237 · Hialeah, FL 33013More trials in Hialeah
- Local Institution - 1229 · Homestead, FL 33030More trials in Homestead
- Local Institution - 1040 · Lady Lake, FL 32159More trials in Lady Lake
- Local Institution - 1159 · Miami, FL 33032More trials in Miami
- Local Institution - 1021 · Miami, FL 33122-1335More trials in Miami
- Local Institution - 1125 · Miami, FL 33135-1601More trials in Miami
- Local Institution - 1236 · Miami, FL 33135-2968More trials in Miami
- Local Institution - 1115 · Miami, FL 33135More trials in Miami
- Local Institution - 1010 · Miami, FL 33137More 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 - 1129 · Miami, FL 33165-3947More trials in Miami
- Local Institution - 1150 · Miami, FL 33165More trials in Miami
- Local Institution - 1006 · Miami, FL 33173-1474More trials in Miami
- Local Institution - 1111 · Miami, FL 33173More trials in Miami
- Local Institution - 1158 · Miami, FL 33175More trials in Miami
- Local Institution - 1235 · Miami, FL 33176-1451More trials in Miami
- Local Institution - 1147 · Miami, FL 33176-7947More trials in Miami
- Local Institution - 1234 · Miami, FL 33176More 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 - 1209 · Miami Lakes, FL 33014More trials in Miami Lakes
- Local Institution - 1118 · Miami Lakes, FL 33016More trials in Miami Lakes
- Aqualane Clinical Research · Naples, FL 34105William Justiz, Site 1246 · Study contact · 941-436-6838More trials in Naples
- Sensible HealthCare, LLC · Ocoee, FL 34761-2964Kelly Taylor, Site 1212 · Study contact · 407-654-2724More trials in Ocoee
- Charter Research Orlando · Orlando, FL 32803Diana Balsalobre, Site 1257 · Study contactMore trials in Orlando
- Nova Psychiatry · Orlando, FL 32803David Medina, Site 1242 · Study contact · 407-823-8421More trials in Orlando
- Combined Research Orlando Phase I-IV LLC · Orlando, FL 32807-3555Eric Carbonell, Site 1112 · Study contact · 407-440-4493More trials in Orlando
- Local Institution - 1204 · Ormond Beach, FL 32174-3101More trials in Ormond Beach
- Local Institution - 1205 · Port Orange, FL 32127-5169More trials in Port Orange
- Local Institution - 1133 · Sweetwater, FL 33182More trials in Sweetwater
- Local Institution - 1123 · Tampa, FL 33614-2869More trials in Tampa
- Guardian Angel Research · Tampa, FL 33614Sadaf Bazargan, Site 1124 · Study contact · 813-300-3300More trials in Tampa
- Interventional Psychiatry of Tampa Bay · Tampa, FL 33629-5837Jamie Fernandez, Site 1110 · Study contact · 813-251-1800More trials in Tampa
- Charter Research · The Villages, FL 32162-2698Jeffrey Norton, Site 1256 · Study contact · 352-775-1000More trials in The Villages
- Local Institution - 1233 · Wellington, FL 33414More trials in Wellington
- Premiere Research Institute at Palm Beach Neurology, PA · West Palm Beach, FL 33407-3209Paul Winner, Site 1216 · Study contact · 561-845-0500More trials in West Palm Beach
GA
- Agile Clinical Research Trials, LLC · Atlanta, GA 30328-5532Vasundhara Cheekati, Site 1206 · Study contact · 404-382-8660More trials in Atlanta
MA
- McLean Hospital · Belmont, MA 02478-1064Arkadiy Stolyar, Site 1223 · Study contact · 617-855-2136More trials in Belmont
- Tufts Medical Center - 800 Washington St - PPDS · Boston, MA 02111-1552Brent Forester, Site 1245 · Study contact · 617-636-3202More trials in Boston
- Boston Neuro Research Center · North Dartmouth, MA 02747-2612Mushtaque Chachar, Site 1243 · Study contact · 508-925-7403More trials in North Dartmouth
- Local Institution - 1250 · South Dartmouth, MA 02747More trials in South Dartmouth
- Elixia Health - Springfield - Elixia - PPDS · Springfield, MA 01103Susan Smiga, Site 1239 · Study contact · 413-305-1142More trials in Springfield
MI
- Neurobehavioral Medicine Group (NBMG) · Bloomfield Township, MI 48302-1909Richard Jackson, Site 1248 · Study contact · 412-916-2425More trials in Bloomfield Township
MO
- Tekton Research, LLC - Saint Louis Psychiatry - PPDS · St Louis, MO 63128Ernest Graypel, Site 1255 · Study contact · 314-594-7785More trials in St Louis
MS
- Precise Research Centers · Flowood, MS 39232Joseph Kwentus, Site 1132 · Study contact · 601-420-5810More trials in Flowood
NC
- Triad Clinical Trials - 515 College Rd · Greensboro, NC 27410-3311Richard Montgomery, Site 1221 · Study contact · 336-235-0991More trials in Greensboro
- AMC Research, LLC - Flourish - PPDS · Matthews, NC 28105-8336Mohammad Bolouri, Site 1214 · Study contact · 704-364-4000More trials in Matthews
- Local Institution - 5005 · Morehead City, NC 28557More trials in Morehead City
- West Clinical Research · Morehead City, NC 28557Patrick Morgante, Site 1215 · Study contact · 252-515-0050More trials in Morehead City
- Local Institution - 1252 · Shelby, NC 28150-3803More trials in Shelby
NJ
- Advanced Memory Research Institute - CenExel - PPDS · Toms River, NJ 08755Arun Singh, Site 1202 · Study contact · 732-341-9500More trials in Toms River
- Local Institution - 1232 · Toms River, NJ 08755More trials in Toms River
NY
- Mid Hudson Medical Research PLLC · New Windsor, NY 12553-7754Sashi Makam, Site 1251 · Study contact · 845-674-9398More trials in New Windsor
- Local Institution - 1231 · Syracuse, NY 13203More trials in Syracuse
- SUNY Upstate Medical University · Syracuse, NY 13210-2306Tinatin Chabrashvili, Site 1240 · Study contact · 617-636-5000More trials in Syracuse
- Five Towns Neurology, PC · Woodmere, NY 11598-1739David Steiner, Site 1025 · Study contact · 516-239-1800More trials in Woodmere
OH
- Local Institution - 1265 · Cleveland, OH 44195Site 1265 · Study contactMore trials in Cleveland
- Ohio State University · Columbus, OH 43221Douglas Scharre, Site 1201 · Study contact · 614-293-4560More trials in Columbus
- Local Institution - 1258 · Dayton, OH 45417-3445Site 1258 · Study contactMore trials in Dayton
- Insight Clinical Trials LLC - Independence · Independence, OH 44131Mark Stillman, Site 1249 · Study contact · 216-444-8897More trials in Independence
OK
- The Rivus Wellness & Research Institute · Oklahoma City, OK 73112Marvin Peyton, Site 1016 · Study contact · 405-317-5783More trials in Oklahoma City
RI
- Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital · Providence, RI 02903Chuang-Kuo Wu, Site 1218 · Study contact · 714-456-7002More trials in Providence
SC
- Local Institution - 1267 · Columbia, SC 29203-8004Site 1267 · Study contactMore trials in Columbia
TN
- Vanderbilt Psychiatric Hospital · Nashville, TN 37212-3133Jo Wilson, Site 1211 · Study contact · 615-322-4967More trials in Nashville
TX
- Senior Adults Specialty Research · Austin, TX 78757-7566John Bertelson, Site 1263 · Study contact · 512-407-8628More trials in Austin
- Local Institution - 1260 · Dallas, TX 75231-6079Site 1260 · Study contactMore trials in Dallas
- Epic Medical Research LLC - DeSoto · DeSoto, TX 75115-2043Haresh Boghara, Site 1121 · Study contact · 972-777-6956More trials in DeSoto
- Advanced Neuro Research Center - El Paso · El Paso, TX 79912-1743Aamr Herekar, Site 1208 · Study contact · 915-974-2200More trials in El Paso
- Local Institution - 1262 · Fort Worth, TX 76104-4143Site 1262 · Study contactMore trials in Fort Worth
- Local Institution - 1261 · Houston, TX 77030-1312Site 1261 · Study contactMore trials in Houston
- University Hills Clinical Research - 102 Decker Ct · Irving, TX 75062-2898Mary Ann Knesevich, Site 1259 · Study contact · 972-717-6262More trials in Irving
- Local Institution - 1238 · Plano, TX 75093-8225More trials in Plano
- Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases · San Antonio, TX 78229-3901Antonio Teixeira, Site 1210 · Study contact · 210-567-8229More trials in San Antonio
- Local Institution - 1134 · Stafford, TX 77477-3929More trials in Stafford
VA
- Local Institution - 1266 · Salem, VA 24153-6404Site 1266 · Study contactMore trials in Salem
- Conquest Research, LLC - Virginia - Vienna · Vienna, VA 22182Henry Tran, Site 1241 · Study contact · 703-717-7755More trials in Vienna
WA
- Northwest Clinical Research Center · Bellevue, WA 98007-4879Wisam Al Jumaili, Site 1253 · Study contact · 425-453-0404More trials in Bellevue
- Local Institution - 1254 · Kirkland, WA 98034More trials in Kirkland