Who is eligible for clinical trial NCT07011732?

Participants must meet protocol criteria for Alzheimer Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07011732 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • 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)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Bristol-Myers Squibb

🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (1 items).

Location: Imaging Endpoints — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay. ii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval. B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:
Amyloid PET.
Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).
Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to: i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.
History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).

Usually NOT eligible if any of the following apply:

Exclusion Criteria \- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia. ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator. iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR. \- Prior/Concomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam). A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted. B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1). C. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1). \- Other protocol-defined Inclusion/Exclusion criteria apply.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (159 Sites)

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

💰 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 § 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.

🏛️ View Official NIH Record ↗