RecruitingPsychosis Associated With Alzheimer's Disease

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

Eligible age

55–90 yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

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About this study

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

You may qualify if…

✓ Is aged 55 to 90 years, inclusive, at Screening
✓ Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met.
✓ i) The subject's legally acceptable representative must provide informed consent; ii) The subject must provide informed consent.
✓ Meets clinical criteria for possible or probable Alzheimer's Disease
✓ Has 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. If not available, a non-contrast brain MRI or non-contrast head CT must be done during screening.
✓ Living at the same location for a minimum of 4 weeks before Screening, with the intention of living at the same location throughout the study.
✓ Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified caregiver or study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant (ie, ≥10 hours per week) on a regular basis to reliably provide accurate information regarding the participant's cognitive, behavioral, and functional status, and is willing to:
✓ i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures; iii) Participate in the study assessments and provide informed consent to participate in the study.

You may not qualify if…

✕ Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia
✕ History of major depressive episode with psychotic features during the 12 months prior to Screening
✕ History of a diagnosis 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
✕ Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of \<50 mL/min
✕ History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke
✕ History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope
✕ Any of the following: