Summary

Eligibility
for people ages 55-90 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

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

Keywords

Alzheimer Disease, Alzheimer's Disease, AD, ADEPT4, ADEPT-4, KarXT, Psychosis, Psychotic Disorders, Mental Disorders

Eligibility

You can join if…

Open to people ages 55-90

  • Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
  • Patients who are diagnosed with possible AD or probable AD (refer to the appendix for the National Institute on Aging - Alzheimer's Association Guidelines for All-cause Dementia and Alzheimer's Disease).
  • 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).

You CAN'T join if...

  • 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.

Locations

  • Local Institution - 1219 not yet accepting patients
    Los Angeles California 90095 United States
  • ATP Clinical Research accepting new patients
    Costa Mesa California 92626-4607 United States
  • Local Institution - 1104 not yet accepting patients
    Anaheim California 92805-5854 United States
  • R & H Clinical Research-3727 Greenbriar Dr accepting new patients
    Stafford Texas 77477-3954 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Karuna Therapeutics
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06585787
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 406 study participants
Last Updated