Alzheimer Disease
Conditions
Keywords
Alzheimer's Disease, AD, ADEPT4, ADEPT-4, KarXT, Psychosis
Brief summary
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
Interventions
DRUGKarXT
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). * Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * Patient 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, eg, major stroke, neoplasm, subdural hematoma. * Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).
Exclusion criteria
\- Patients will not be able to participate if they have: i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features. ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities. \* Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score | Up to Week 14 |
Secondary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score (IPSS) | Up to Week 14 |
| Number of participants with suicidal ideation and behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | Up to Week 14 |
| Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) | Up to Week 14 |
| Change from baseline in NPI-C Core score: Caregiver Distress Scale | Up to Week 14 |
| Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score | Up to Week 14 |
| Number of participants with Adverse Events (AEs) | Up to Week 14 |
| Number of participants with Treatment-Emergent Adverse Events (TEAEs) | Up to Week 14 |
| Number of participants with Serious Adverse Events (SAEs) | Up to Week 14 |
| Number of participants with TEAEs leading to study withdrawal | Up to Week 14 |
| Number of participants with procholinergic symptoms | Up to Week 14 |
| Number of participants with anticholinergic symptoms | Up to Week 14 |
| Number of participants with AEs of Special Interest (AESIs) | Up to Week 14 |
| Barnes Akathisia Rating Scale (BARS) Score | Up to Week 14 |
| Abnormal Involuntary Movement Scale (AIMS) Score | Up to Week 14 |
| Body Weight | Up to Week 14 |
| Body Mass Index (BMI) | Up to Week 14 |
| Number of participants with vital sign abnormalities | Up to Week 14 |
| Number of participants with clinical laboratory abnormalities | Up to Week 14 |
| Number of participants with 12-lead electrocardiogram (ECG) abnormalities | Up to Week 14 |
| Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale | Up to Week 14 |
| Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain | Up to Week 14 |
| Change from baseline in NPI-C Core score: Delusion Domain | Up to Week 14 |
| Change from baseline in NPI-C Core score: Agitation Domain | Up to Week 14 |
| Change from baseline in NPI-C Core score: Aggression Domain | Up to Week 14 |
| Cognition as assessed by the Mini-Mental State Examination (MMSE) | Up to Week 14 |
| Change from baseline in NPI-C Agitation score | Up to Week 14 |
Countries
Argentina, Belgium, Brazil, Bulgaria, China, Croatia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Poland, Portugal, Puerto Rico, Romania, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed