KarXT + KarX-EC for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination, KarXT and KarX-EC, for people with Alzheimer's who experience agitation. The goal is to assess the long-term safety and effectiveness of this treatment. Participants must have taken part in a previous study and have a caregiver who spends at least 10 hours a week with them. Those with serious health issues, such as untreated high blood pressure or unstable heart conditions, are not eligible. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination treatment KarXT and KarX-EC has been studied for safety in adults with Alzheimer's-related agitation. Earlier studies examined how well participants tolerated these treatments. Results suggest that the treatment is generally well-tolerated, with most side effects being mild to moderate, such as dry mouth and constipation. Serious side effects were rare.
Since this trial is in a later phase, researchers have already gathered substantial safety information. This typically indicates that the treatment is considered safe enough for testing in large groups. Participants who join will be closely monitored by the trial team to manage any side effects.12345Why do researchers think this study treatment might be promising for Alzheimer's Disease?
Researchers are excited about KarXT + KarX-EC for Alzheimer's disease because these treatments target the condition in a novel way. Unlike traditional treatments that mainly focus on managing symptoms through neurotransmitter regulation, KarXT + KarX-EC work by stimulating muscarinic receptors, which are believed to play a role in cognitive function. This approach offers the potential to not only alleviate symptoms but also address the underlying cognitive deficits associated with Alzheimer's. Additionally, these treatments could provide a more effective and faster-acting option compared to existing therapies like cholinesterase inhibitors and memantine.
What evidence suggests that this treatment might be an effective treatment for Alzheimer's Disease?
Research has shown that KarXT + KarX-EC, the treatment under study in this trial, may help reduce agitation in people with Alzheimer's disease. Studies have found that this combination can lessen symptoms like restlessness and aggression. KarXT affects certain parts of the brain, which may help calm these behaviors. Previous patients demonstrated improvements in agitation and related symptoms with this treatment. This suggests that KarXT + KarX-EC could be a promising option for managing agitation in Alzheimer's patients.14678
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for people who have Alzheimer's Disease with symptoms of agitation and completed previous studies CN012-0023 or CN012-0024. They must also have a caregiver available for at least 10 hours per week.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KarXT + KarX-EC for the treatment of agitation associated with Alzheimer's Disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive KarXT + KarX-EC to evaluate long-term safety and tolerability
What Are the Treatments Tested in This Trial?
Interventions
- KarXT + KarX-EC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania