ACTIVE_NOT_RECRUITING

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

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, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

Official Title

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

Quick Facts

Study Start:2023-08-28
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06126224

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. 1. Is a male or female aged 55 to 90 years, inclusive, at Screening.
  2. 2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
  3. 3. Meets clinical criteria for Possible AD or Probable AD.
  4. 4. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
  5. 5. Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
  6. 6. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
  7. 7. CGI-S scale with a score ≥ 4 at Screening and Baseline.
  8. 8. AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline:
  9. 1. Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR
  10. 2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
  11. 9. MMSE score of 8 to 22, inclusive, at Screening.
  1. 1. Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
  2. 2. History of major depressive episode with psychotic features during the 12 months prior to Screening.
  3. 3. History of bipolar disorder, schizophrenia, or schizoaffective disorder.
  4. 4. Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition 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.
  5. 5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
  6. 6. Prior exposure to KarXT.
  7. 7. History of hypersensitivity to KarXT excipients or trospium chloride.
  8. 8. Experienced any significant adverse events (AEs) due to trospium.
  9. 9. Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the 12 months prior to Screening.

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 1116
Chandler, Arizona, 85286
United States
Local Institution - 1044
Phoenix, Arizona, 85012-2836
United States
Local Institution - 1104
Anaheim, California, 92805-5854
United States
Local Institution - 1119
Canoga Park, California, 91303-1844
United States
Local Institution - 1151
Encino, California, 91316
United States
Local Institution - 1142
Lancaster, California, 93534-2839
United States
Local Institution - 1117
Los Alamitos, California, 90720-6506
United States
Local Institution - 1103
Sherman Oaks, California, 91403-2131
United States
Local Institution - 1007
Walnut Creek, California, 94596
United States
Local Institution - 1156
Clermont, Florida, 34711-5190
United States
Local Institution - 1138
Cutler Bay, Florida, 33189-1230
United States
Local Institution - 1162
Delray Beach, Florida, 33445-2581
United States
Local Institution - 1164
Doral, Florida, 33122-1620
United States
Local Institution - 1165
Fort Myers, Florida, 33912-4302
United States
Local Institution - 1155
Hialeah, Florida, 33012-3158
United States
Local Institution - 1107
Hialeah, Florida, 33012-3618
United States
Local Institution - 1120
Hialeah, Florida, 33012-4648
United States
Local Institution - 1140
Hialeah, Florida, 33016-1814
United States
Local Institution - 0150
Homestead, Florida, 33032-8187
United States
Local Institution - 1145
Homestead, Florida, 33032-8187
United States
Local Institution - 1127
Largo, Florida, 33777-1359
United States
Local Institution - 1039
Maitland, Florida, 32751-5669
United States
Local Institution - 1146
Maitland, Florida, 32751-6138
United States
Local Institution - 1126
Miami Gardens, Florida, 33056-4000
United States
Local Institution - 1102
Miami Lakes, Florida, 33014-6435
United States
Local Institution - 1159
Miami, Florida, 33032
United States
Local Institution - 1118
Miami, Florida, 33122-1721
United States
Local Institution - 1111
Miami, Florida, 33126-5683
United States
Local Institution - 1108
Miami, Florida, 33133-4231
United States
Local Institution - 1125
Miami, Florida, 33135-1601
United States
Local Institution - 1115
Miami, Florida, 33135
United States
Local Institution - 1143
Miami, Florida, 33145-2455
United States
Local Institution - 1113
Miami, Florida, 33155-6630
United States
Local Institution - 1009
Miami, Florida, 33155
United States
Local Institution - 1129
Miami, Florida, 33165-3947
United States
Local Institution - 1150
Miami, Florida, 33165
United States
Local Institution - 1109
Miami, Florida, 33174-2950
United States
Local Institution - 1158
Miami, Florida, 33175
United States
Local Institution - 1147
Miami, Florida, 33176-7947
United States
Local Institution - 1105
Miami, Florida, 33179-2537
United States
Local Institution - 1157
Miami, Florida, 33184-1412
United States
Local Institution - 1101
Okeechobee, Florida, 34972-2568
United States
Local Institution - 1136
Orlando, Florida, 32806-1041
United States
Local Institution - 1112
Orlando, Florida, 32807-3555
United States
Local Institution - 1137
Port Orange, Florida, 32127-2914
United States
Local Institution - 1133
Sweetwater, Florida, 33182
United States
Local Institution - 1041
Tampa, Florida, 33607-4629
United States
Local Institution - 1124
Tampa, Florida, 33614-2700
United States
Local Institution - 1123
Tampa, Florida, 33614-2846
United States
Local Institution - 1110
Tampa, Florida, 33629-5837
United States
Local Institution - 1131
Viera, Florida, 32940
United States
Local Institution - 1161
Decatur, Georgia, 30030
United States
Local Institution - 1148
Elgin, Illinois, 60123-9215
United States
Local Institution - 1114
Marrero, Louisiana, 70072-3083
United States
Local Institution - 1139
Rochester Hills, Michigan, 48307-2760
United States
Local Institution - 1132
Flowood, Mississippi, 39232
United States
Local Institution - 1122
Dayton, Ohio, 45459-4248
United States
Local Institution - 1106
Cypress, Texas, 77429-6070
United States
Local Institution - 1163
Houston, Texas, 77074-2085
United States
Local Institution - 1154
Katy, Texas, 77450-1759
United States
Local Institution - 1134
Stafford, Texas, 77477-3929
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 Date2023-08-28
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2023-08-28
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Psychosis Associated With Alzheimer's Disease