Recruiting at 109 sites Phase 3 Alzheimer's Disease

Alzheimer's Disease study: KarXT vs KarX-EC

Official title A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

ClinicalTrials.gov ID: NCT06976203

What this study is testing

What is KarXT?

KarXT is an investigational oral medication being studied for cognitive impairment in Alzheimer’s disease.

Also referred to as BMS-986510.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to find out whether KarXT + KarX-EC is effective and safe for treating cognitive impairment in Alzheimer’s disease.
Who it's for
The study is looking for people who have Alzheimer’s disease.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 60 to 85

You may be able to join if

  • Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages...
  • 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...
  • Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to...

You likely can't join if

  • Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or...
  • Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with...
  • 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...
  • Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that could affect safety or...
  • Other protocol-defined Inclusion/Exclusion criteria apply.

The study team makes the final eligibility decision.

Where it is enrolling

  • Fullerton, California, United States
  • Irvine, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • Colorado Springs, Colorado, United States
  • Fort Myers, Florida, United States
  • Jacksonville, Florida, United States
  • Lady Lake, Florida, United States
  • Sarasota, Florida, United States
  • Tampa, Florida, United States
  • Wellington, Florida, United States
  • Chicago, Illinois, United States
  • Springfield, Illinois, United States
  • Indianapolis, Indiana, United States
  • Farmington Hills, Michigan, United States
  • Hattiesburg, Mississippi, United States
  • Springfield, New Jersey, United States
  • West Long Branch, New Jersey, United States
  • Albany, New York, United States
  • Amherst, New York, United States

+ 83 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 60 years to 85 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Fullerton, California, United States; Irvine, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Colorado Springs, Colorado, United States; Fort Myers, Florida, United States and 97 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.