Vanderbilt Clinical Trials

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Purpose

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.

Condition

Alzheimer Disease

Eligibility

Eligible Ages: Between 55 Years and 90 Years
Eligible Sex: All
Accepts 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 National Institute on Aging - Alzheimer's Association criteria with AD biomarker confirmation. - 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/Exclusion criteria apply.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental KarXT		Drug: KarXT Specified dose on specified days Other names: BMS-986510
Experimental Placebo		Drug: Placebo Specified dose on specified days

Recruiting Locations

Vanderbilt Psychiatric Hospital
Nashville 4644585, Tennessee 4662168 37212-3133

Contact:
Jo Wilson, Site 1211
615-322-4967

More Details

Status: Recruiting
Sponsor: Karuna Therapeutics

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.