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RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 1)

Who can join

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

Age
60 Years to 85 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 + KarX-EC works and how safe it is for memory and thinking problems caused by Alzheimer's disease. It is for people with confirmed Alzheimer's disease and mild or moderate dementia.

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

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

Eligibility

Who can join

  • Have confirmed Alzheimer's disease with mild (stage 4) or moderate (stage 5) dementia, based on the required diagnosis guidelines.
  • Score 12 to 22 on the Mini-Mental State Examination (MMSE), a memory and thinking test, at screening.
  • Have a caregiver who spends about 10 or more hours a week with you and will attend all study visits.
  • The caregiver must report on your health, help make sure you take your medicine, and agree to take part in study tasks.
  • If you take Alzheimer's medicines called AChEIs or memantine, your dose must be unchanged for at least 12 weeks before screening and stay the same during the study.

Who can't join

  • Have a serious health problem that could make the study unsafe, keep you from finishing it, or affect the results.
  • Have any liver problems, trouble emptying your bladder, active gallbladder or bile duct disease, or moderate to severe kidney problems (eGFR below 50, a kidney filtering measure).
  • Have blood pressure that is high and not stable, or a fast heartbeat that is not stable.
  • Have a main mental health diagnosis such as major depression, schizoaffective disorder, or bipolar disorder, or severe mental health symptoms that could affect study testing or completion.
  • Have a history of schizophrenia or other long-term psychosis, which can make it hard to tell what is real.
  • Have taken KarXT before, or have received Alzheimer's treatments that target a protein called amyloid within 6 months before screening.
  • Have a brain MRI scan at screening showing major problems other than Alzheimer's disease, or findings that could affect safety or study tasks.
  • 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

Inclusion Criteria * Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach. * Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening. * Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities. * Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration. Exclusion Criteria * Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \<50 mL/min), and unstable hypertension or tachycardia. * Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion. * Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening. * Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that reflect significant pathology other than AD or could affect safety or interfere with study procedures. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study sites (28)

CA

CO

DC

FL

GA

IL

MA

MN

NC

NJ

NY

OH

OR

PA

RI

TN

TX