Trial · NCT07011732
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, Phase 3, Recruiting, Bristol-Myers Squibb
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT07011732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07011732
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT07011732
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 426 participants, estimated
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Alzheimer Disease
- Interventions
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Placebo
- First posted
- 2025-06-10
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14 | At Week 14 | |
| Secondary | Change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14 | At Week 14 | |
| Secondary | Change from baseline on the CMAI-IPA Domains at Week 14 | At Week 14 | |
| Secondary | Change from baseline on the CMAI Total Score at Week 14 | At Week 14 | |
| Secondary | Number of participants with Occurrence of Response at Week 14 | At Week 14 | As determined by CMAI-IPA Total Score changes of at least 30%, 40%, and 50% from baseline |
| Secondary | Change from baseline on the Neuropsychiatric Inventory/Neuropsychiatric Inventory -Nursing Home (NPI/NPI-NH) Total Score at Week 14 | At Week 14 | |
| Secondary | Number of participants with Adverse Events (AEs) | Up to Week 18 | |
| Secondary | Number of participants with Treatment Emergent AEs (TEAEs) | Up to Week 18 | |
| Secondary | Number of participants with Serious AEs (SAEs) | Up to Week 18 | |
| Secondary | Number of participants with AEs leading to study drug withdrawal | Up to Week 14 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07011732
GET https://conductscience.org/api/trials/v1/NCT07011732/registered?page=2