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)

Purpose

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

Condition

  • Psychosis Associated With Alzheimer's Disease

Eligibility

Eligible Ages
Between 55 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Must have completed study CN012-0026, CN012-0027 or CN012-0056. - Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027 or CN012-0056 study. - Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, the subject's legally acceptable representative must provide informed consent, and the subject must provide informed assent before any study assessments are performed. - At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study. - Have an identified or proxy caregiver (spends approximately 10 hours/week with the subject).

Exclusion Criteria

  • Significant or severe medical conditions 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. - Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study CN012-0026, CN012-0027 or CN012-0056 that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject. - Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of CN012-0028. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT 		Xanomeline and Trospium Chloride Capsules
  • Drug: KarXT
    KarXT 20/2 mg TID (total daily dose [TDD] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)

Recruiting Locations

Advanced Research Center, Inc.
Anaheim 5323810, California 5332921 92805-5854
Contact:
Steven Macina, Site 1104
714-999-6688

USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
Los Angeles 5368361, California 5332921 90033-5313
Contact:
Lon Schneider, Site 1226
323-442-3715

SC3 Research - Pasadena - 960 E. Green St
Pasadena 5381396, California 5332921 91106
Contact:
M. Lorraine Purino, Site 1043
626-250-2070

California Neuroscience Research - CenExel - PPDS
Sherman Oaks 5395244, California 5332921 91403-2131
Contact:
MARIA SELIVERSTOV, Site 1103
818-990-2671

University of Connecticut Health Center
Farmington 4834272, Connecticut 4831725 06030
Contact:
Neha Jain, Site 1222
860-790-7354

K2 Medical Research - Winter Garden
Clermont 4151352, Florida 4155751 34711-5933
Contact:
Christopher Galloway, Site 1048
321-500-5252

JY Research Institute Inc
Cutler Bay 6332309, Florida 4155751 33189-1230
Contact:
Suez Oramas Mingo, Site 1138
305-424-8696

Arrow Clinical Trials
Daytona Beach 4152872, Florida 4155751 32117-5532
Contact:
David Billmeier, Site 1023
386-278-8000

Integrity Clinical Research, LLC - 8000 NW 21st St
Doral 4153471, Florida 4155751 33122-1620
Contact:
Lucinda Cuervo-Ramos, Site 1164
305-888-0410

Betancourt Research Services
Doral 4153471, Florida 4155751 33172-2638
Contact:
Beatriz Triana, Site 1045
786-741-2287

Superior Associates in Research LLC
Hialeah 4158476, Florida 4155751 33012-3158
Contact:
Amnerys Garcia, Site 1155
305-246-0873

Direct Helpers Research Center
Hialeah 4158476, Florida 4155751 33012-3618
Contact:
Manuel Fernandez, Site 1107
305-828-3555

New Life Medical Research Center -3750 W 16th Ave
Hialeah 4158476, Florida 4155751 33012-4648
Contact:
Jorge Betancourt, Site 1120
305-456-7782

Las Mercedes Medical Research - 4440 West 16th Ave
Hialeah 4158476, Florida 4155751 33012
Contact:
Frank Carlos Alvarez Li, Site 1052
786-334-6675

Galiz Research
Hialeah 4158476, Florida 4155751 33016-1814
Contact:
Jose Gamez, Site 1140
305-805-0921

Nexus Clinical Research Center- NRC
Homestead 4159050, Florida 4155751 33030
Contact:
John Cintron, Site 1229

Coral Clinic Research
Homestead 4159050, Florida 4155751 33032
Contact:
Nelson Gonzalez, Site 1049
786-715-2200

Homestead Associates in Research Inc-30328 Old Dixie Hwy
Homestead 4159050, Florida 4155751 33033
Contact:
Angel Carrasco, Site 1159
786-422-7374

K2 Medical Research - Maitland
Maitland 4163220, Florida 4155751 32751-5669
Contact:
Brandon Lenox, Site 1039
407-670-5833

Premier Clinical Research Institute
Miami 4164138, Florida 4155751 33122-1335
Contact:
Emelina Arocha, Site 1021
305-445-5994

Angels Clinical Research Institute - Miami
Miami 4164138, Florida 4155751 33122-1721
Contact:
Yanely Pineiro Puebla, Site 1118
786-218-1733

CCM Clinical Research Group
Miami 4164138, Florida 4155751 33133-4231
Contact:
Francisco Ricart, Site 1108
208-346-8900

Wellness Research Center Inc - Miami
Miami 4164138, Florida 4155751 33135-1601
Contact:
Brian Villa, Site 1125
786-238-7099

A & D Doctor Center
Miami 4164138, Florida 4155751 33135-2968
Contact:
Yordan Orive Gomez, Site 1236
305-223-2000

Floridian Neuroscience Institute-1901 SW 1 St
Miami 4164138, Florida 4155751 33135
Contact:
Emilio Mantero-Atienza, Site 1115
305-326-0776

MedOne Clinical Research LLC
Miami 4164138, Florida 4155751 33145-2455
Contact:
Thierry Jacquemin, Site 1143
305-359-7666

Allied Biomedical Research Institute
Miami 4164138, Florida 4155751 33155-4630
Contact:
Michael Pfeffer, Site 1009
866-879-2507

My Community Research Center, Inc - 7480 Bird Rd
Miami 4164138, Florida 4155751 33155-6630
Contact:
Cesar Guerrero, Site 1113
786-359-4867

Future Care Solution LLC
Miami 4164138, Florida 4155751 33165-3947
Contact:
Pilar Trueba, Site 1129
305-888-0410

Reliant Medical Research
Miami 4164138, Florida 4155751 33165
Contact:
Carlos Ramirez Calderon, Site 1150
786-801-0912

Dade Research Center - Miami FL - 7600 SW 87th Ave
Miami 4164138, Florida 4155751 33173
Contact:
Maria Nualart, Site 1111
305-263-7120

Florida Research Center, Inc.
Miami 4164138, Florida 4155751 33174-2950
Contact:
Sonia Rente, Site 1109
305-551-8493

US Associates in Research Inc
Miami 4164138, Florida 4155751 33175
Contact:
Christopher Jimenez, Site 1158
305-246-0873

Serenity Research Center
Miami 4164138, Florida 4155751 33176-1451
Contact:
Sergio Jaramillo, Site 1235
305-596-2080

IMIC LLC- 9380 SW 150th Str
Miami 4164138, Florida 4155751 33176-7947
Contact:
Leon Ramon, Site 1147
786-600-7005

New Gen Health
Miami 4164138, Florida 4155751 33176
Contact:
Roberto Hernando, Site 1234
305-892-1035

Floridian Research Institute-1021 Ives Dairy Rd
Miami 4164138, Florida 4155751 33179-2537
Contact:
Gretel Trullenque, Site 1105
786-391-1137

High Quality Research
Miami 4164138, Florida 4155751 33184-1412
Contact:
Jorge Gonzalez, Site 1157
305-392-0244

Coral Research Clinic & Coral Diagnostic Center
Miami 4164138, Florida 4155751 33186-4643
Contact:
Jorge Paoli Bruno, Site 1054
000-000-0000

ONHEALTH Research Center
Miami 4164138, Florida 4155751 33186-5882
Contact:
Maria Rodil, Site 1042
786-808-0832

New Med Research
Miami Gardens 4164167, Florida 4155751 33056-4000
Contact:
Marta Fernandez, Site 1126
305-269-7100

San Marcus Research Clinic Inc
Miami Lakes 4164186, Florida 4155751 33014-5602
Contact:
Nancy Navarro Gonzalez, Site 1032

Meridian International Research
Miami Lakes 4164186, Florida 4155751 33014-6435
Contact:
Gonzalo Quesada, Site 1102
305-705-4494

Ocean Blue Medical Research Center Inc
Miami Springs 4164223, Florida 4155751 33166-5260
Contact:
Antonio Terrelonge, Site 1026
305-885-8983

Combined Research Orlando Phase I-IV LLC
Orlando 4167147, Florida 4155751 32807-3555
Contact:
Eric Carbonell, Site 1112
407-440-4493

Neurology Associates of Ormond Beach
Ormond Beach 4167178, Florida 4155751 32174-3101
Contact:
David McDonald, Site 1204
386-673-2500

Cordova Research Institute- Sweetwater
Sweetwater 4174600, Florida 4155751 33182
Contact:
Delores Macksoud, Site 1133
786-631-3890

Guardian Angel Research - ClinEdge - PPDS
Tampa 4174757, Florida 4155751 33614-2700
Contact:
Sadaf Bazargan, Site 1124
813-300-3300

Angels Clinical Research Institute Tampa - Palm Springs - PPDS
Tampa 4174757, Florida 4155751 33614-2869
Contact:
Al Robaina, Site 1123
813-931-0128

Interventional Psychiatry of Tampa Bay
Tampa 4174757, Florida 4155751 33629-5837
Contact:
Jamie Fernandez, Site 1110
813-251-1800

Premiere Research Institute at Palm Beach Neurology, PA
West Palm Beach 4177887, Florida 4155751 33407-3209
Contact:
Paul Winner, Site 1216
561-845-0500

Agile Clinical Research Trials, LLC
Atlanta 4180439, Georgia 4197000 30328-5532
Contact:
Vasundhara Cheekati, Site 1206
404-382-8660

Precise Research Centers
Flowood 4426822, Mississippi 4436296 39232
Contact:
Joseph Kwentus, Site 1132
601-420-5810

Bio Behavioral Health - 20 Hospital Dr
Toms River 4504476, New Jersey 5101760 08755
Contact:
Ashok Patel, Site 1232
732-244-2299

Five Towns Neurology PC -Woodmere - 923 Broadway
Woodmere 5145028, New York 5128638 11598-1739
Contact:
David Steiner, Site 1025
516-239-1800

Horizon Clinical Research: Gill Neuroscience
Cypress 4684724, Texas 4736286 77429-6070
Contact:
Harpaul Gill, Site 1106
949-491-0710

Clinical Trial Network - 7080 Southwest Fwy
Houston 4699066, Texas 4736286 77074-2085
Contact:
Nelson Berrios, Site 1004

Barbara Diaz Hernandez MD Research Inc
San Juan 4568127, Puerto Rico 00926-3160
Contact:
Ileana Fumero-Perez, Site 1304

More Details

NCT ID
NCT05980949
Status
Recruiting
Sponsor
Karuna Therapeutics

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center