KarXT + KarX-EC for Agitation in Alzheimer's Disease

Recruiting at 151 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: MAO inhibitors, Anticonvulsants, Mood stabilizers, Tricyclics

Disqualifiers: Bipolar, Schizophrenia, Urinary retention, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

352 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new treatments, KarXT and KarX-EC, to evaluate their effectiveness and safety for adults experiencing agitation due to Alzheimer's disease. The study compares these treatments to a placebo (a substance with no active medication) to assess their effectiveness. Participants must have an Alzheimer's diagnosis and have experienced agitation for at least two weeks. Additionally, participants should have a caregiver to assist with study requirements. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatments for Alzheimer's-related agitation.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications to join the trial. If you are taking monoamine oxidase inhibitors, anticonvulsants, mood stabilizers, or tricyclic antidepressants, you might need to discontinue them. However, if you are on a stable dose of selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors for at least 8 weeks, you may be allowed to continue.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of KarXT and KarX-EC is being tested for safety in treating agitation in Alzheimer's patients. Earlier results suggest that patients generally tolerate this treatment well. Common side effects include mild to moderate issues like dry mouth and constipation, with few reports of serious side effects. As the study progresses into a later phase, researchers have gathered extensive safety information, helping to identify any major risks. Testing for long-term use also indicates confidence in its safety over time. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about KarXT + KarX-EC for treating agitation in Alzheimer's disease because it offers a novel approach compared to traditional options like antipsychotics. KarXT combines xanomeline, a muscarinic receptor agonist, with trospium, which limits peripheral side effects, offering a unique mechanism of action that targets brain pathways involved in agitation. This combination could potentially improve symptoms more effectively and safely than current treatments, which often come with significant side effects. The addition of KarX-EC, an extended-release formulation, may enhance patient compliance and provide more consistent symptom management.

What evidence suggests that this trial's treatments could be effective for agitation in Alzheimer's Disease?

Research has shown that KarXT, a combination of xanomeline and trospium chloride, may help treat agitation in people with Alzheimer's Disease. In this trial, participants will receive either the experimental treatment KarXT combined with KarX-EC or a placebo. Studies suggest that the KarXT combination can reduce symptoms of agitation. Xanomeline targets brain areas that affect mood and behavior, while trospium chloride helps lessen side effects. Early results indicate that this treatment might improve the quality of life for those experiencing agitation due to Alzheimer's. As with any treatment, results can vary from person to person, but the findings so far are promising. ^{2 4 5 6 7}

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 adults with Alzheimer's who experience agitation. Specific criteria will determine eligibility, but the main requirements are not provided in the information given.

Inclusion Criteria

Having one identified caregiver willing to attend visits, report on participant's status, oversee compliance, and participate in study assessments

Mini-Mental State Examination (MMSE) score of 5 to 22 at Screening

History of agitation meeting IPA consensus definition with specific NPI/NPI-NH Agitation/Aggression and CGI-S scores

Exclusion Criteria

History of bipolar disorder, schizophrenia, or schizoaffective disorder

Risk of suicidal behavior

I haven't taken any restricted medications recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KarXT + KarX-EC or placebo for the treatment of agitation associated with Alzheimer's Disease

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KarX-EC
• KarXT

Trial Overview The study tests KarXT + KarX-EC, which includes Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule, against a placebo to see if they're safe and can reduce agitation in Alzheimer's patients.

How Is the Trial Designed?

Group I: KarXT + KarX-EC Experimental Treatment 2 Interventions

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07011745

NCT07011745 | A Phase 3 Study to Evaluate the Safety ... The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

2. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT06937229

Trial ID CN012-0025 | NCT06937229 - BMS Clinical Trials Trial ID CN012-0025 | NCT06937229. A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06937229?term=AREA%5BConditionSearch%5D(karxt%20OR%20%22kuru%20encephalopathy%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=2&checkSpell=

A Study to Evaluate the Long-term Efficacy and Safety ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-of-trospium-chloride-and-xanomeline-tartrate-combination-for-agitation-in-alzheimers-disease-patients-long-term-safety-evaluation/

Study of trospium chloride and xanomeline tartrate ... This study focuses on testing medications called KarXT and KarX-EC in people who have Alzheimer's Disease with agitation.

5. bmsstudyconnect.com bmsstudyconnect.com/it/en/clinical-trials/NCT07011745.html

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT ... The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07011745

NCT07011745 | A Phase 3 Study to Evaluate the Safety ... The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07011732?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Bristol-Myers%20Squibb%22))&rank=8

A Phase 3 Study to Evaluate the Safety and Efficacy of ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...