Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

ClinicalTrials.gov ID: NCT05980949

Public ClinicalTrials.gov record NCT05980949. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 4, 2026, 3:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Study identification

NCT ID: NCT05980949
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company; Industry
Enrollment: 800 participants

Conditions and interventions

Conditions

Psychosis Associated With Alzheimer's Disease

Interventions

KarXT Drug

Drug

Eligibility (public fields only)

Age range: 55 Years to 90 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 10, 2023
Primary completion: Sep 6, 2027
Completion: Sep 6, 2027
Last update posted: Apr 20, 2026

2023 – 2027

United States locations

U.S. sites: 143
U.S. states: 22
U.S. cities: 92

Facility	City	State	ZIP	Site status
Local Institution - 1029	Homewood	Alabama	35209-6809	Withdrawn
Local Institution - 1-13H98LK9	Chandler	Arizona	85224-6231	Withdrawn
Local Institution - 1227	Chandler	Arizona	85224	Withdrawn
Local Institution - 1116	Chandler	Arizona	85286	Withdrawn
Local Institution - 1247	Gilbert	Arizona	85297	Not yet recruiting
Local Institution - 1217	Phoenix	Arizona	85006-2528	Not yet recruiting
Local Institution - 1044	Phoenix	Arizona	85012-2836	Withdrawn
Local Institution - 1220	Scottsdale	Arizona	85260-6742	Not yet recruiting
Advanced Research Center, Inc.	Anaheim	California	92805-5854	Recruiting
Local Institution - 1-141NO1DG	Chino	California	91710	Not yet recruiting
Local Institution - 1001	Costa Mesa	California	92626	Withdrawn
Local Institution - 1151	Encino	California	91316	Withdrawn
Local Institution - 1033	Encino	California	91436-2201	Withdrawn
Local Institution - 1031	Irvine	California	92612-1246	Withdrawn
Local Institution - 1230	Lakewood	California	90805-4549	Not yet recruiting
Local Institution - 1142	Lancaster	California	93534-2839	Withdrawn
Local Institution - 1117	Los Alamitos	California	90720-6506	Withdrawn
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)	Los Angeles	California	90033-5313	Recruiting
Local Institution - 1228	Orange	California	92868-2847	Not yet recruiting
SC3 Research - Pasadena - 960 E. Green St	Pasadena	California	91106	Recruiting
Local Institution - 1213	Rancho Cucamonga	California	91730	Not yet recruiting
California Neuroscience Research - CenExel - PPDS	Sherman Oaks	California	91403-2131	Recruiting
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS	Walnut Creek	California	94596	Recruiting
Local Institution - 1014	Colorado Springs	Colorado	80907-5302	Withdrawn
University of Connecticut Health Center	Farmington	Connecticut	06030	Recruiting
Local Institution - 1013	Stamford	Connecticut	06905-1206	Withdrawn
Local Institution - 1225	Atlantis	Florida	33462	Withdrawn
Local Institution - 1011	Boca Raton	Florida	33487-2768	Withdrawn
Envision Trials LLC	Bonita Springs	Florida	34134	Recruiting
Local Institution - 1015	Bradenton	Florida	34209-4687	Withdrawn
Local Institution - 1156	Clermont	Florida	34711-5190	Withdrawn
K2 Medical Research - Winter Garden	Clermont	Florida	34711-5933	Recruiting
JY Research Institute Inc	Cutler Bay	Florida	33189-1230	Recruiting
Arrow Clinical Trials	Daytona Beach	Florida	32117-5532	Recruiting
Local Institution - 1224	Deerfield Beach	Florida	33442	Withdrawn
Local Institution - 1162	Delray Beach	Florida	33445-2581	Withdrawn
Integrity Clinical Research, LLC - 8000 NW 21st St	Doral	Florida	33122-1620	Recruiting
Betancourt Research Services	Doral	Florida	33172-2638	Recruiting
Local Institution - 1165	Fort Myers	Florida	33912-4302	Withdrawn
Superior Associates in Research LLC	Hialeah	Florida	33012-3158	Recruiting
Direct Helpers Research Center	Hialeah	Florida	33012-3618	Recruiting
New Life Medical Research Center -3750 W 16th Ave	Hialeah	Florida	33012-4648	Recruiting
Local Institution - 1046	Hialeah	Florida	33012-5826	Not yet recruiting
Las Mercedes Medical Research - 4440 West 16th Ave	Hialeah	Florida	33012	Recruiting
Local Institution - 1-13JED81K	Hialeah	Florida	33013	Withdrawn
Local Institution - 1237	Hialeah	Florida	33013	Not yet recruiting
Galiz Research	Hialeah	Florida	33016-1814	Recruiting
Nexus Clinical Research Center- NRC	Homestead	Florida	33030	Recruiting
Local Institution - 1145	Homestead	Florida	33032-8187	Withdrawn
Coral Clinic Research	Homestead	Florida	33032	Recruiting
Homestead Associates in Research Inc-30328 Old Dixie Hwy	Homestead	Florida	33033	Recruiting
Local Institution - 1127	Largo	Florida	33777-1359	Withdrawn
K2 Medical Research - Maitland	Maitland	Florida	32751-5669	Recruiting
Local Institution - 1146	Maitland	Florida	32751-6138	Withdrawn
Premier Clinical Research Institute	Miami	Florida	33122-1335	Recruiting
Angels Clinical Research Institute - Miami	Miami	Florida	33122-1721	Recruiting
Local Institution - 1005	Miami	Florida	33125-3724	Not yet recruiting
CCM Clinical Research Group	Miami	Florida	33133-4231	Recruiting
Wellness Research Center Inc - Miami	Miami	Florida	33135-1601	Recruiting
A & D Doctor Center	Miami	Florida	33135-2968	Recruiting
Floridian Neuroscience Institute-1901 SW 1 St	Miami	Florida	33135	Recruiting
Local Institution - 1010	Miami	Florida	33137	Withdrawn
MedOne Clinical Research LLC	Miami	Florida	33145-2455	Recruiting
Allied Biomedical Research Institute	Miami	Florida	33155-4630	Recruiting
My Community Research Center, Inc - 7480 Bird Rd	Miami	Florida	33155-6630	Recruiting
Future Care Solution LLC	Miami	Florida	33165-3947	Recruiting
Reliant Medical Research	Miami	Florida	33165	Recruiting
South Florida Research Phase I-IV, Inc. - Miami	Miami	Florida	33166	Recruiting
Novel Clinical Research Center, LLC -7000 SW 97th Ave	Miami	Florida	33173-1474	Recruiting
Dade Research Center - Miami FL - 7600 SW 87th Ave	Miami	Florida	33173	Recruiting
Florida Research Center, Inc.	Miami	Florida	33174-2950	Recruiting
US Associates in Research Inc	Miami	Florida	33175	Recruiting
Serenity Research Center	Miami	Florida	33176-1451	Recruiting
IMIC LLC- 9380 SW 150th Str	Miami	Florida	33176-7947	Recruiting
New Gen Health	Miami	Florida	33176	Recruiting
Floridian Research Institute- Ives Dairy Road	Miami	Florida	33179-2537	Recruiting
High Quality Research	Miami	Florida	33184-1412	Recruiting
Coral Research Clinic & Coral Diagnostic Center	Miami	Florida	33186-4643	Recruiting
ONHEALTH Research Center	Miami	Florida	33186-5882	Recruiting
New Med Research	Miami Gardens	Florida	33056-4000	Recruiting
San Marcus Research Clinic Inc	Miami Lakes	Florida	33014-5602	Recruiting
Meridian International Research	Miami Lakes	Florida	33014-6435	Recruiting
Local Institution - 1209	Miami Lakes	Florida	33014	Withdrawn
Ocean Blue Medical Research Center Inc	Miami Springs	Florida	33166-5260	Recruiting
Local Institution - 1246	Naples	Florida	34105	Not yet recruiting
Local Institution - 1212	Ocoee	Florida	34761-2964	Not yet recruiting
Local Institution - 1101	Okeechobee	Florida	34972-2568	Withdrawn
Nova Psychiatry	Orlando	Florida	32803	Recruiting
Local Institution - 1136	Orlando	Florida	32806-1041	Withdrawn
Combined Research Orlando Phase I-IV LLC	Orlando	Florida	32807-3555	Recruiting
Neurology Associates of Ormond Beach	Ormond Beach	Florida	32174-3101	Recruiting
Local Institution - 1012	Pensacola	Florida	32504-8608	Withdrawn
Local Institution - 1137	Port Orange	Florida	32127-2914	Withdrawn
Local Institution - 1205	Port Orange	Florida	32127	Not yet recruiting
Local Institution - 1008	St. Petersburg	Florida	33713-8844	Withdrawn
Cordova Research Institute- Sweetwater	Sweetwater	Florida	33182	Recruiting
Local Institution - 1041	Tampa	Florida	33607-4629	Not yet recruiting
Guardian Angel Research - ClinEdge - PPDS	Tampa	Florida	33614-2700	Recruiting
Angels Clinical Research Institute Tampa - Palm Springs - PPDS	Tampa	Florida	33614-2869	Recruiting
Interventional Psychiatry of Tampa Bay	Tampa	Florida	33629-5837	Recruiting
Local Institution - 1040	The Villages	Florida	32159-8955	Not yet recruiting
Local Institution - 1131	Viera	Florida	32940	Withdrawn
Premiere Research Institute at Palm Beach Neurology, PA	West Palm Beach	Florida	33407-3209	Recruiting
Agile Clinical Research Trials, LLC	Atlanta	Georgia	30328-5532	Recruiting
Local Institution - 1161	Decatur	Georgia	30030	Withdrawn
Local Institution - 1037	Berwyn	Illinois	60402-2173	Withdrawn
Local Institution - 1148	Elgin	Illinois	60123-9215	Withdrawn
Local Institution - 1114	Marrero	Louisiana	70072-3083	Withdrawn
Local Institution - 1223	Belmont	Massachusetts	02478-1064	Not yet recruiting
Local Institution - 1245	Boston	Massachusetts	02111-1552	Not yet recruiting
Local Institution - 1243	North Dartmouth	Massachusetts	02747-2612	Not yet recruiting
Local Institution - 1239	Springfield	Massachusetts	01103	Not yet recruiting
Local Institution - 1-146Y4PVY	Bloomfield Township	Michigan	48302-1909	Not yet recruiting
Local Institution - 1139	Rochester Hills	Michigan	48307-2760	Withdrawn
Precise Research Centers	Flowood	Mississippi	39232	Recruiting
Local Institution - 1202	Toms River	New Jersey	08755	Not yet recruiting
Local Institution - 1232	Toms River	New Jersey	08755	Not yet recruiting
Local Institution - 1018	Manhasset	New York	11030-3816	Withdrawn
Local Institution - 1017	New York	New York	10032	Withdrawn
Local Institution - 1034	Stony Brook	New York	11794-0001	Withdrawn
Local Institution - 1231	Syracuse	New York	13203	Withdrawn
Local Institution - 1240	Syracuse	New York	13210-1718	Not yet recruiting
Five Towns Neurology PC -Woodmere - 923 Broadway	Woodmere	New York	11598-1739	Recruiting
Local Institution - 1221	Greensboro	North Carolina	27410-3311	Not yet recruiting
AMC Research, LLC - Flourish - PPDS	Matthews	North Carolina	28105-8336	Recruiting
Local Institution - 1215	Morehead City	North Carolina	28557	Not yet recruiting
Local Institution - 1201	Columbus	Ohio	43210	Not yet recruiting
Local Institution - 1122	Dayton	Ohio	45459-4248	Withdrawn
Local Institution - 1249	Shaker Heights	Ohio	44122-5288	Not yet recruiting
Local Institution - 1016	Oklahoma City	Oklahoma	73112	Not yet recruiting
Local Institution - 1218	Providence	Rhode Island	02903	Withdrawn
Local Institution - 1035	Charleston	South Carolina	29425-8900	Withdrawn
Local Institution - 1211	Nashville	Tennessee	37212-3133	Not yet recruiting
Horizon Clinical Research: Gill Neuroscience	Cypress	Texas	77429-6070	Recruiting
Local Institution - 1121	DeSoto	Texas	75115-2043	Not yet recruiting
Local Institution - 1208	El Paso	Texas	79912-1743	Not yet recruiting
Local Institution - 1022	Flower Mound	Texas	75028-2011	Withdrawn
Local Institution - 1036	Frisco	Texas	75034-6262	Withdrawn
Clinical Trial Network - 7080 Southwest Fwy	Houston	Texas	77074-2085	Recruiting
Local Institution - 1238	Plano	Texas	75093-8225	Not yet recruiting
Local Institution - 1210	San Antonio	Texas	78229-3901	Not yet recruiting
Local Institution - 1134	Stafford	Texas	77477-3929	Withdrawn
Local Institution - 1241	Arlington	Virginia	22205	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 273 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05980949, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 20, 2026 · Synced May 4, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05980949 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →