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.

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, California 92805-5854
Contact:
Steven Macina, Site 1104
714-493-7258

California Neuroscience Research - CenExel - PPDS
Sherman Oaks, California 91403-2131
Contact:
Maria Seliverstov, Site 1103
818-990-2671

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

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

Arrow Clinical Trials
Daytona Beach, Florida 32117-5532
Contact:
David Billmeier, Site 1023
386-304-7070

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

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

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

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

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

Las Mercedes Medical Research - 4440 West 16th Ave
Hialeah, Florida 33012
Contact:
Frank Alvarez, Site 1052
786-577-5977

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

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

Homestead Associates in Research Inc-30328 Old Dixie Hwy
Homestead, Florida 33033
Contact:
Angel Carrasco, Site 1159
305-246-0873

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

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

San Marcus Research Clinic Inc
Miami Lakes, Florida 33014-5602
Contact:
Nancy Navarro Gonzalez, Site 1032
305-424-7420

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

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

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

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

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

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

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

Floridian Neuroscience Institute-1901 SW 1 St
Miami, Florida 33135
Contact:
Emilio Mantero-Atienza, Site 1115
305-330-9977

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

Allied Biomedical Research Institute
Miami, Florida 33155-4630
Contact:
Michael Pfeffer, Site 1009
305-643-8400

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

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

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

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

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

US Associates in Research Inc
Miami, Florida 33175
Contact:
Christopher Jimenez, Site 1158
786-275-4023

Serenity Research Center
Miami, Florida 33176-1451
Contact:
Sergio Jaramillo, Site 1235
786-558-4823

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

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

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

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

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

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

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

Cordova Research Institute- Sweetwater
Sweetwater, Florida 33182
Contact:
Delores Macksoud, Site 1133
786-542-0297

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

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

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

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

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

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

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

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

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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Vanderbilt University Medical Center