RecruitingPhase 3

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well KarXT works and how safe it is compared with a placebo, a treatment with no active drug. It is for adults ages 55 to 90 with mild to severe Alzheimer's disease and moderate to severe psychosis, such as seeing things that are not there or having false beliefs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 55 to 90 years old and meet medical criteria for possible or probable Alzheimer's disease.
  • Understand the study and its rules and give consent or agreement before any study tests.
  • Have a brain MRI or CT scan from the past 5 years, taken after dementia began, to rule out other causes. If no scan is available, have one during screening.
  • Have lived in the same home or assisted-living facility for at least 6 weeks before screening.
  • Have a study partner with daily contact totaling about 10 hours a week or more.
  • Have had psychosis symptoms, such as false beliefs or seeing things that are not there, for at least 2 months before screening.
  • Meet required symptom scores at screening and the study's start: CGI-S of at least 4, and NPI-C of at least 6, with moderate to severe symptoms on at least 2 items for false beliefs or hallucinations.
  • Score 8 to 22 on the MMSE, a test of memory and thinking, at screening.

Who can't join

  • Have psychosis mainly caused by a condition other than Alzheimer's disease.
  • Have had major depression with psychosis in the past 12 months, or a history of bipolar disorder, schizophrenia, or schizoaffective disorder.
  • Have a serious health condition that the study doctor thinks could make participation unsafe, prevent completion of study steps, or affect the results.
  • Have a history or high risk of trouble emptying the bladder or stomach, or narrow-angle glaucoma, an eye condition.
  • Have taken KarXT before.
  • Have had an allergic reaction to KarXT's inactive ingredients or trospium chloride, or a serious unwanted effect from trospium.
  • Have received an experimental drug in another study within 3 months before screening, or joined more than 2 clinical studies in the past 12 months.
  • Other study rules may also affect whether you can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (70)

AZ

CA

FL

GA

IL

LA

MI

MS

NV

NY

OH

PA

TX