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Trial · NCT06947941

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

NCT06947941, Phase 3, Recruiting, Bristol-Myers Squibb

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5). Trials, record NCT06947941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06947941

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
NCT number
NCT06947941
Status
Recruiting
Phases
Phase 3
Enrollment
325 participants, estimated
Lead sponsor
Bristol-Myers Squibb
Conditions
Alzheimer Disease, Psychosis
Interventions
KarXT, KarX-EC, KarXT + KarX-EC Arm Matching Placebo
First posted
2025-04-27
Last updated
2026-06-30

Source ClinicalTrials.gov

Registered outcomes32

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) ScoreUp to approximately Week 14
SecondaryChange From Baseline in Clinical Global Impressions-Severity (CGI-S) ScoreUp to approximately Week 14
SecondaryChange From Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) Core ScoreUp to approximately Week 14NPI-C Core Score includes assessment for hallucinations, delusions, agitation, and aggression domains
SecondaryChange From Baseline in NPI-C: Agitation ScoreUp to approximately Week 14
SecondaryChange From Baseline in NPI-C Core Score: Caregiver Distress ScaleUp to approximately Week 14NPI-C Core Score: Caregiver Distress Scale includes assessment for hallucinations, delusions, agitation, and aggression domains
SecondaryResponder RateUp to approximately Week 14Responder rate is defined as improvement from baseline in NPI-C: H+D score ≥ 40%.
SecondaryChange From Baseline in Cohen-Mansfield Agitation Inventory International Psychogeriatric Association (CMAI-IPA) ScoreUp to approximately Week 14
SecondaryChange From Baseline in CMAI Total ScoreUp to approximately Week 14
SecondaryNumber of Participants With Adverse Events (AEs)Up to approximately Week 14
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)Up to approximately Week 14

Outcomes0

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT06947941

GET https://conductscience.org/api/trials/v1/NCT06947941/registered?page=2