RECRUITING

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

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Conditions

Psychosis Associated With Alzheimer's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027, CN012-0056 or CN012-0034. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study, 14-week CN012-0056 or 14 week CN012-0034 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 and KarXT + KarX-EC in subjects with psychosis associated with Alzheimer's Disease.

Official Title

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

Quick Facts

Study Start:2023-07-11
Study Completion:2027-09-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05980949

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have completed study CN012-0026, CN012-0027, CN012-0034 or CN012-0056.
  2. * Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027, CN012-0034 or CN012-0056 study.
  3. * 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.
  4. * 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.
  5. * Have an identified or proxy caregiver (spends approximately 10 hours/week with the subject).
  1. * 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.
  2. * 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, CN012-0034 or CN012-0056 that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
  3. * Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of CN012-0028.
  4. * Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 1029
Homewood, Alabama, 35209-6809
United States
Local Institution - 1-13H98LK9
Chandler, Arizona, 85224-6231
United States
Local Institution - 1227
Chandler, Arizona, 85224-6231
United States
Local Institution - 1116
Chandler, Arizona, 85286
United States
Local Institution - 1217
Phoenix, Arizona, 85006-2528
United States
Local Institution - 1044
Phoenix, Arizona, 85012-2836
United States
Local Institution - 1220
Scottsdale, Arizona, 85260-6742
United States
Advanced Research Center, Inc.
Anaheim, California, 92805-5854
United States
Local Institution - 1001
Costa Mesa, California, 92626
United States
Local Institution - 1151
Encino, California, 91316
United States
Local Institution - 1033
Encino, California, 91436-2201
United States
Local Institution - 1031
Irvine, California, 92612-1246
United States
Local Institution - 1230
Lakewood, California, 90805-4549
United States
Local Institution - 1142
Lancaster, California, 93534-2839
United States
Local Institution - 1117
Los Alamitos, California, 90720-6506
United States
Local Institution - 1226
Los Angeles, California, 90033-5313
United States
Local Institution - 1228
Orange, California, 92868-2847
United States
Local Institution - 1043
Pasadena, California, 91105-3132
United States
Local Institution - 1213
Rancho Cucamonga, California, 91730
United States
California Neuroscience Research - CenExel - PPDS
Sherman Oaks, California, 91403-2131
United States
Local Institution - 1007
Walnut Creek, California, 94596
United States
Local Institution - 1014
Colorado Springs, Colorado, 80907-5302
United States
Local Institution - 1222
Farmington, Connecticut, 06030
United States
Local Institution - 1013
Stamford, Connecticut, 06905-1206
United States
Local Institution - 1225
Atlantis, Florida, 33462
United States
Local Institution - 1011
Boca Raton, Florida, 33487-2768
United States
Local Institution - 1020
Bonita Springs, Florida, 34134-4154
United States
Local Institution - 1015
Bradenton, Florida, 34209-4687
United States
Local Institution - 1156
Clermont, Florida, 34711-5190
United States
K2 Medical Research - Winter Garden
Clermont, Florida, 34711-5933
United States
JY Research Institute Inc
Cutler Bay, Florida, 33189-1230
United States
Arrow Clinical Trials
Daytona Beach, Florida, 32117-5532
United States
Local Institution - 1224
Deerfield Beach, Florida, 33442
United States
Local Institution - 1162
Delray Beach, Florida, 33445-2581
United States
Integrity Clinical Research, LLC - 8000 NW 21st St
Doral, Florida, 33122-1620
United States
Betancourt Research Services
Doral, Florida, 33172-2638
United States
Local Institution - 1165
Fort Myers, Florida, 33912-4302
United States
Superior Associates in Research LLC
Hialeah, Florida, 33012-3158
United States
Direct Helpers Research Center
Hialeah, Florida, 33012-3618
United States
New Life Medical Research Center -3750 W 16th Ave
Hialeah, Florida, 33012-4648
United States
Local Institution - 1046
Hialeah, Florida, 33012-5826
United States
Las Mercedes Medical Research - 4440 West 16th Ave
Hialeah, Florida, 33012
United States
Local Institution - 1-13JED81K
Hialeah, Florida, 33013
United States
Local Institution - 1237
Hialeah, Florida, 33013
United States
Galiz Research
Hialeah, Florida, 33016-1814
United States
Local Institution - 1229
Homestead, Florida, 33030
United States
Local Institution - 1145
Homestead, Florida, 33032-8187
United States
Coral Clinic Research
Homestead, Florida, 33032
United States
Homestead Associates in Research Inc-30328 Old Dixie Hwy
Homestead, Florida, 33033
United States
Local Institution - 1127
Largo, Florida, 33777-1359
United States
K2 Medical Research - Maitland
Maitland, Florida, 32751-5669
United States
Local Institution - 1146
Maitland, Florida, 32751-6138
United States
Premier Clinical Research Institute - Miami - ClinEdge - PPDS
Miami, Florida, 33122-1335
United States
Angels Clinical Research Institute - Miami
Miami, Florida, 33122-1721
United States
Local Institution - 1005
Miami, Florida, 33125-3724
United States
CCM Clinical Research Group
Miami, Florida, 33133-4231
United States
Wellness Research Center Inc - Miami
Miami, Florida, 33135-1601
United States
A & D Doctor Center
Miami, Florida, 33135-2968
United States
Floridian Neuroscience Institute-1901 SW 1 St
Miami, Florida, 33135
United States
Local Institution - 1010
Miami, Florida, 33137
United States
MedOne Clinical Research LLC
Miami, Florida, 33145-2455
United States
Allied Biomedical Research Institute
Miami, Florida, 33155-4630
United States
My Community Research Center, Inc - 7480 Bird Rd
Miami, Florida, 33155-6630
United States
Future Care Solution LLC
Miami, Florida, 33165-3947
United States
Reliant Medical Research
Miami, Florida, 33165
United States
Local Institution - 1006
Miami, Florida, 33173-1474
United States
Dade Research Center - Miami FL - 7600 SW 87th Ave
Miami, Florida, 33173
United States
Florida Research Center, Inc.
Miami, Florida, 33174-2950
United States
US Associates in Research Inc
Miami, Florida, 33175
United States
Serenity Research Center
Miami, Florida, 33176-1451
United States
IMIC LLC- 9380 SW 150th Str
Miami, Florida, 33176-7947
United States
New Gen Health
Miami, Florida, 33176
United States
Floridian Research Institute-1021 Ives Dairy Rd
Miami, Florida, 33179-2537
United States
High Quality Research
Miami, Florida, 33184-1412
United States
Coral Research Clinic & Coral Diagnostic Center
Miami, Florida, 33186-4643
United States
ONHEALTH Research Center
Miami, Florida, 33186-5882
United States
New Med Research
Miami Gardens, Florida, 33056-4000
United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, 33014-5602
United States
Meridian International Research
Miami Lakes, Florida, 33014-6435
United States
Local Institution - 1209
Miami Lakes, Florida, 33014
United States
Ocean Blue Medical Research Center Inc
Miami Springs, Florida, 33166-5260
United States
Local Institution - 1053
Miami Springs, Florida, 33166-7225
United States
Local Institution - 1212
Ocoee, Florida, 34761-2964
United States
Local Institution - 1101
Okeechobee, Florida, 34972-2568
United States
Local Institution - 1136
Orlando, Florida, 32806-1041
United States
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807
United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174-3101
United States
Local Institution - 1012
Pensacola, Florida, 32504-8608
United States
Local Institution - 1137
Port Orange, Florida, 32127-2914
United States
Local Institution - 1205
Port Orange, Florida, 32127
United States
Local Institution - 1008
St. Petersburg, Florida, 33713-8844
United States
Cordova Research Institute- Sweetwater
Sweetwater, Florida, 33182
United States
Local Institution - 1041
Tampa, Florida, 33607-4629
United States
Guardian Angel Research - ClinEdge - PPDS
Tampa, Florida, 33614-2700
United States
Angels Clinical Research Institute Tampa - Palm Springs - PPDS
Tampa, Florida, 33614-2869
United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, 33629-5837
United States
Local Institution - 1040
The Villages, Florida, 32159-8955
United States
Local Institution - 1131
Viera, Florida, 32940
United States
Local Institution - 1216
West Palm Beach, Florida, 33407-3209
United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328-5532
United States
Local Institution - 1161
Decatur, Georgia, 30030
United States
Local Institution - 1037
Berwyn, Illinois, 60402-2173
United States
Local Institution - 1148
Elgin, Illinois, 60123-9215
United States
Local Institution - 1114
Marrero, Louisiana, 70072-3083
United States
Local Institution - 1223
Belmont, Massachusetts, 02478-1064
United States
Local Institution - 1239
Springfield, Massachusetts, 01103
United States
Local Institution - 1139
Rochester Hills, Michigan, 48307-2760
United States
Precise Research Centers - ClinEdge - PPDS
Flowood, Mississippi, 39232
United States
Bio Behavioral Health - 20 Hospital Dr
Toms River, New Jersey, 08755
United States
Local Institution - 1202
Toms River, New Jersey, 08755
United States
Local Institution - 1018
Manhasset, New York, 11030-3816
United States
Local Institution - 1017
New York, New York, 10032
United States
Local Institution - 1034
Stony Brook, New York, 11794-0001
United States
Local Institution - 1231
Syracuse, New York, 13203
United States
Five Towns Neurology PC -Woodmere - 923 Broadway
Woodmere, New York, 11598-1739
United States
Local Institution - 1221
Greensboro, North Carolina, 27410-3311
United States
Local Institution - 1214
Matthews, North Carolina, 28105-8336
United States
Local Institution - 1215
Morehead City, North Carolina, 28557
United States
Local Institution - 1201
Columbus, Ohio, 43210
United States
Local Institution - 1122
Dayton, Ohio, 45459-4248
United States
Local Institution - 1218
Providence, Rhode Island, 02903
United States
Local Institution - 1035
Charleston, South Carolina, 29425-8900
United States
Local Institution - 1211
Nashville, Tennessee, 37212-3133
United States
Horizon Clinical Research: Gill Neuroscience
Cypress, Texas, 77429-6070
United States
Local Institution - 1121
DeSoto, Texas, 75115-2043
United States
Local Institution - 1208
El Paso, Texas, 79912-1743
United States
Local Institution - 1022
Flower Mound, Texas, 75028-2011
United States
Local Institution - 1036
Frisco, Texas, 75034-6262
United States
Clinical Trial Network - 7080 Southwest Fwy
Houston, Texas, 77074-2085
United States
Local Institution - 1238
Plano, Texas, 75093-8225
United States
Local Institution - 1210
San Antonio, Texas, 78229-3901
United States
Local Institution - 1134
Stafford, Texas, 77477-3929
United States
Local Institution - 1241
Arlington, Virginia, 22205
United States

Collaborators and Investigators

Sponsor: Karuna Therapeutics

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-11
Study Completion Date2027-09-07

Study Record Updates

Study Start Date2023-07-11
Study Completion Date2027-09-07

Terms related to this study

Additional Relevant MeSH Terms

  • Psychosis Associated With Alzheimer's Disease