KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

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

Recruiting Phase 3 Interventional Study
Alzheimer's Disease
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
60 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
586 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for

This trial is looking for people with mild to moderate Alzheimer's disease who want to help test a new treatment. Participants will need a caregiver to support them and attend study visits.

Are You a Good Fit for This Trial?
Must be taking Acetyl choline esterase inhibitorsMemantine
Rules you out Hepatic impairmentUrinary retentionActive biliary diseaseModerate-severe renal impairmentUnstable hypertensionTachycardia

You may be able to join if

  • I have a confirmed diagnosis of Alzheimer's disease.
  • I am at the mild or moderate dementia stage.
  • I have a Mini-Mental State Examination score between 12 and 22.
  • I have a caregiver who will support me and attend study visits.
  • I have been taking stable doses of AChEIs or memantine for at least 12 weeks.

You may not be able to join if

  • I have any significant medical conditions that could affect my safety.
  • I have a primary psychiatric diagnosis like major depression or bipolar disorder.
  • I have a history of schizophrenia or chronic psychosis.
  • I have significant problems on my brain MRI that are not due to Alzheimer's.
  • I am currently being treated with disease-modifying anti-amyloid therapies for Alzheimer's.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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

Trial Locations
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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 pat…
Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

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