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

Recruiting · NCT06126224 · Interventional (participants receive a specific treatment) · Lead sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

View the official record on ClinicalTrials.gov →

Alzheimer's disease

Interventions studied

KarXTPlacebo

What this trial is about

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.

Who can take part

Age range

55 Years to 90 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Is a male or female aged 55 to 90 years, inclusive, at Screening.
Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
Meets clinical criteria for Possible AD or Probable AD.
Must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening.
Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
CGI-S scale with a score ≥ 4 at Screening and Baseline.
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:
Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR
Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
MMSE score of 8 to 22, inclusive, at Screening.
Key

Exclusion criteria

Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
History of major depressive episode with psychotic features during the 12 months prior to Screening.
History of bipolar disorder, schizophrenia, or schizoaffective disorder.
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.
History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
Prior exposure to KarXT.
History of hypersensitivity to KarXT excipients or trospium chloride.
Experienced any significant adverse events (AEs) due to trospium.
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.
Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

60 locations listed across 13 US states.

Local Institution - 1116 - Chandler, Arizona, United States
Local Institution - 1044 - Phoenix, Arizona, United States
Local Institution - 1104 - Anaheim, California, United States
Local Institution - 1119 - Canoga Park, California, United States
Local Institution - 1151 - Encino, California, United States
Local Institution - 1142 - Lancaster, California, United States
Local Institution - 1117 - Los Alamitos, California, United States
Local Institution - 1103 - Sherman Oaks, California, United States
Local Institution - 1007 - Walnut Creek, California, United States
Local Institution - 1160 - Apopka, Florida, United States
Local Institution - 1156 - Clermont, Florida, United States
Local Institution - 1138 - Cutler Bay, Florida, United States
Local Institution - 1162 - Delray Beach, Florida, United States
Local Institution - 1164 - Doral, Florida, United States
Local Institution - 1165 - Fort Myers, Florida, United States
Local Institution - 1155 - Hialeah, Florida, United States
Local Institution - 1107 - Hialeah, Florida, United States
Local Institution - 1120 - Hialeah, Florida, United States
Local Institution - 1140 - Hialeah, Florida, United States
Local Institution - 0150 - Homestead, Florida, United States
Local Institution - 1145 - Homestead, Florida, United States
Local Institution - 1127 - Largo, Florida, United States
Local Institution - 1039 - Maitland, Florida, United States
Local Institution - 1146 - Maitland, Florida, United States
Local Institution - 1159 - Miami, Florida, United States
Local Institution - 1118 - Miami, Florida, United States
Local Institution - 1111 - Miami, Florida, United States
Local Institution - 1108 - Miami, Florida, United States
Local Institution - 1125 - Miami, Florida, United States
Local Institution - 1115 - Miami, Florida, United States
Local Institution - 1143 - Miami, Florida, United States
Local Institution - 1113 - Miami, Florida, United States
Local Institution - 1009 - Miami, Florida, United States
Local Institution - 1129 - Miami, Florida, United States
Local Institution - 1150 - Miami, Florida, United States
Local Institution - 1109 - Miami, Florida, United States
Local Institution - 1158 - Miami, Florida, United States
Local Institution - 1147 - Miami, Florida, United States
Local Institution - 1105 - Miami, Florida, United States
Local Institution - 1157 - Miami, Florida, United States
Local Institution - 1126 - Miami Gardens, Florida, United States
Local Institution - 1102 - Miami Lakes, Florida, United States
Local Institution - 1136 - Orlando, Florida, United States
Local Institution - 1112 - Orlando, Florida, United States
Local Institution - 1137 - Port Orange, Florida, United States
Health Synergy Clinical Research,LLC - Stuart - Stuart, Florida, United States
Local Institution - 1133 - Sweetwater, Florida, United States
Local Institution - 1041 - Tampa, Florida, United States
Local Institution - 1124 - Tampa, Florida, United States
Local Institution - 1123 - Tampa, Florida, United States
Local Institution - 1110 - Tampa, Florida, United States
Local Institution - 1040 - The Villages, Florida, United States
Local Institution - 1131 - Viera, Florida, United States
Local Institution - 1152 - Augusta, Georgia, United States
Local Institution - 1141 - Columbus, Georgia, United States
Local Institution - 1161 - Decatur, Georgia, United States
Local Institution - 1148 - Elgin, Illinois, United States
Local Institution - 1114 - Marrero, Louisiana, United States
Local Institution - 1139 - Rochester Hills, Michigan, United States
Local Institution - 1132 - Flowood, Mississippi, United States

Showing 60 of 154 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →