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RECRUITING Phase 3

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

NCT06976216 · View on ClinicalTrials.gov ↗

Study Summary

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

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG KarXT
  • DRUG KarX-EC

Study Locations (20)

Florida

  • JEM Research Institute — Atlantis
  • VIN-Julie Schwartzbard — Aventura
  • Merritt Island Medical Research, LLC — Merritt Island
  • Renstar Medical Research — Ocala
  • Alzheimer's Research and Treatment Center — Stuart
  • Charter Research - Lady Lake — The Villages

New York

  • Local Institution - 0101 — New York
  • Local Institution - 0259 — New York
  • SUNY Upstate Medical University — Syracuse

California

  • Healthy Brain Clinic — Long Beach
  • Anderson Clinical Research — Redlands

Georgia

  • Local Institution - 0016 — Columbus
  • Center for Advanced Research & Education — Gainesville

Illinois

  • Re:Cognition Health - Chicago — Chicago
  • Ascension Alexian Brothers — Elk Grove Village

Colorado

  • Mountain Neurological Research Center — Basalt

District of Columbia

  • Georgetown University Medical Center — Washington D.C.

Massachusetts

  • Boston Center for Memory — Newton

Trial Details

FieldValue
Enrollment Target 586 participants
Start Date 2025-07-14
Est. Completion 2029-02-23
Phase Phase 3

Sponsor

Bristol-Myers Squibb

504 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06976216

The ClinicalTrials.gov registry entry for NCT06976216 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 586 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Alzheimer's Disease appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06976216 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06976216 about?

NCT06976216 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease". The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

What is the current status of trial NCT06976216?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 586 participants. The study started on 2025-07-14. Estimated completion is 2029-02-23.

What conditions does trial NCT06976216 study?

This clinical trial studies the following conditions: Alzheimer's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06976216?

The interventions under investigation include: Placebo (OTHER), KarXT (DRUG), KarX-EC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06976216?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06976216 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial