๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-10

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1) (NCT07011732)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Bristol-Myers Squibb

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Imaging Endpoints โ€” Scottsdale, Arizona

Age range: 55 Years to 90 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (159 Sites)

Showing the first 25 of 159 sites.

  • Imaging Endpoints โ€” Scottsdale, Arizona
  • Advanced Research Center (ARC) - Anaheim โ€” Anaheim, California
  • Local Institution - 1637 โ€” La Jolla, California
  • The Neurology Group โ€” Pomona, California
  • Local Institution - 1639 โ€” Torrance, California
  • Sunwise Clinical Research โ€” Walnut Creek, California
  • Local Institution - 1630 โ€” Colorado Springs, Colorado
  • Local Institution - 1622 โ€” Maitland, Florida
  • Local Institution - 1631 โ€” Maitland, Florida
  • Local Institution - 1666 โ€” Merritt Island, Florida
  • Local Institution - 1602 โ€” Miami, Florida
  • Local Institution - 1618 โ€” Miami, Florida
  • Hope Research Network - Miami โ€” Miami, Florida
  • Local Institution - 1604 โ€” Miami, Florida
  • Local Institution - 1608 โ€” Ocala, Florida
  • Combined Research Orlando (CRO) โ€” Orlando, Florida
  • Progressive Medical Research โ€” Port Orange, Florida
  • Local Institution - 1655 โ€” Marrero, Louisiana
  • CBH Health โ€” Gaithersburg, Maryland
  • Local Institution - 1663 โ€” Foxborough, Massachusetts
  • Boston Center for Memory โ€” Newton, Massachusetts
  • Mayflower Clinical Research โ€” South Dartmouth, Massachusetts
  • Elixia MA โ€” Springfield, Massachusetts
  • NeuroBehavioral Medicine Group โ€” Bloomfield Hills, Michigan
  • Oakland Medical Research โ€” Troy, Michigan

๐Ÿ“ž Contact the Study Coordinator

Phone: (855) 907-3286

Email: Clinical.Trials@bms.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—