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.
Eligibility
Sex
ALL
Min age
55 Years
Max age
90 Years
Healthy volunteers
No
Key Inclusion Criteria:
1. Is a male or female aged 55 to 90 years, inclusive, at Screening.
2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
3. Meets clinical criteria for Possible AD or Probable AD.
4. 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.
5. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
6. Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
7. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
8. CGI-S scale with a score ≥ 4 at Screening and Baseline.
9. 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:
1. Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR
2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
10. MMSE score of 8 to 22, inclusive, at Screening.
Key Exclusion Criteria:
1. Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
2. History of major depressive episode with psychotic features during the 12 months prior to Screening.
3. History of bipolar disorder, schizophrenia, or schizoaffective disorder.
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. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
6. Prior exposure to KarXT.
7. History of hypersensitivity to KarXT excipients or trospium chloride.
8. Experienced any significant adverse events (AEs) due to trospium.
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.
10. Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score — Baseline and end of Treatment (up to 14 Weeks) Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
Trial sites (154)
Facility
City
Region
Status
Local Institution - 1116
Chandler
Arizona
Active Not Recruiting
Local Institution - 1044
Phoenix
Arizona
Active Not Recruiting
Local Institution - 1104
Anaheim
California
Active Not Recruiting
Local Institution - 1119
Canoga Park
California
Active Not Recruiting
Local Institution - 1151
Encino
California
Active Not Recruiting
Local Institution - 1142
Lancaster
California
Active Not Recruiting
Local Institution - 1117
Los Alamitos
California
Active Not Recruiting
Local Institution - 1103
Sherman Oaks
California
Active Not Recruiting
Local Institution - 1007
Walnut Creek
California
Active Not Recruiting
Local Institution - 1160
Apopka
Florida
Withdrawn
Local Institution - 1156
Clermont
Florida
Active Not Recruiting
Local Institution - 1138
Cutler Bay
Florida
Active Not Recruiting
Local Institution - 1162
Delray Beach
Florida
Active Not Recruiting
Local Institution - 1164
Doral
Florida
Active Not Recruiting
Local Institution - 1165
Fort Myers
Florida
Active Not Recruiting
Local Institution - 1155
Hialeah
Florida
Active Not Recruiting
Local Institution - 1107
Hialeah
Florida
Active Not Recruiting
Local Institution - 1120
Hialeah
Florida
Active Not Recruiting
Local Institution - 1140
Hialeah
Florida
Active Not Recruiting
Local Institution - 0150
Homestead
Florida
Active Not Recruiting
Local Institution - 1145
Homestead
Florida
Active Not Recruiting
Local Institution - 1127
Largo
Florida
Active Not Recruiting
Local Institution - 1039
Maitland
Florida
Active Not Recruiting
Local Institution - 1146
Maitland
Florida
Active Not Recruiting
Local Institution - 1159
Miami
Florida
Active Not Recruiting
Local Institution - 1118
Miami
Florida
Active Not Recruiting
Local Institution - 1111
Miami
Florida
Active Not Recruiting
Local Institution - 1108
Miami
Florida
Active Not Recruiting
Local Institution - 1125
Miami
Florida
Active Not Recruiting
Local Institution - 1115
Miami
Florida
Active Not Recruiting
Local Institution - 1143
Miami
Florida
Active Not Recruiting
Local Institution - 1113
Miami
Florida
Active Not Recruiting
Local Institution - 1009
Miami
Florida
Active Not Recruiting
Local Institution - 1129
Miami
Florida
Active Not Recruiting
Local Institution - 1150
Miami
Florida
Active Not Recruiting
Local Institution - 1109
Miami
Florida
Active Not Recruiting
Local Institution - 1158
Miami
Florida
Active Not Recruiting
Local Institution - 1147
Miami
Florida
Active Not Recruiting
Local Institution - 1105
Miami
Florida
Active Not Recruiting
Local Institution - 1157
Miami
Florida
Active Not Recruiting
+ 114 more sites — see the full list on the official registry below.
More Karuna Therapeutics, Inc., a Bristol Myers Squibb company trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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