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A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 71 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 293 → 296 locations Secondary endpoints: details revised at 1 of 26 entries · Eligibility criteria expanded, about 4 words Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 26 entries
    • Eligibility criteria expanded, about 4 words
  2. Study sites: 292 to 293v70
  3. Study sites revised (292)v69 See this version in full on ClinicalTrials.gov ↗
  4. Trial sites expanded: 289 → 292 locationsv68
  5. Study sites revised (289)v67 See this version in full on ClinicalTrials.gov ↗
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites revised (289)v66 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 288 to 289v65
  1. Primary completion pushed from Sep 21, 2026 to Nov 24, 2026 Trial sites expanded: 281 → 288 locations · Completion pushed from Oct 19, 2026 to Dec 22, 2026v64 Show 2 more changesShow less
    • Trial sites expanded: 281 → 288 locations
    • Completion pushed from Oct 19, 2026 to Dec 22, 2026
  2. Study sites: 280 to 281v63
  3. Sponsor changed: Karuna Therapeutics to Karuna Therapeutics, Inc., a Bristol Myers Squibb company Study sites: 278 to 280v62 Show 1 more changeShow less
    • Study sites: 278 to 280

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 277 to 278v61
  5. Eligibility criteria revised Secondary endpoints: 27 to 26 · Study sites revised (277)v60 Show 2 more changesShow less
    • Secondary endpoints: 27 to 26
    • Study sites revised (277)

    See this version in full on ClinicalTrials.gov ↗

  6. Site details revised at 1 of 277 sitesv59
  7. Study sites: 274 to 277v58
  8. Study sites: 267 to 274v57
  9. Study sites revised (267)v56 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 265 to 267v55
  11. Study sites: 264 to 265v54
  12. Study sites: 261 to 264v53
  13. Study sites revised (261)v52 See this version in full on ClinicalTrials.gov ↗
  14. Study sites revised (261)v51 See this version in full on ClinicalTrials.gov ↗
  15. Study sites revised (261)v50 See this version in full on ClinicalTrials.gov ↗
  16. Study sites: 260 to 261v49
  17. Study sites revised (260)v48 See this version in full on ClinicalTrials.gov ↗
  18. Study sites revised (260)v47 See this version in full on ClinicalTrials.gov ↗
  19. Study sites revised (260)v46 See this version in full on ClinicalTrials.gov ↗
  20. Study sites revised (260)v45 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 254 to 260v44
  22. Study sites: 252 to 254v43
  23. Study sites: 247 to 252v42
  24. Study sites revised (247)v41 See this version in full on ClinicalTrials.gov ↗
  25. Study sites revised (247)v40 See this version in full on ClinicalTrials.gov ↗
  26. Study sites: 240 to 247v39
  27. Study sites: 238 to 240v38
  28. Study sites: 234 to 238v37
  29. Study sites: 230 to 234v36
  30. Study sites: 229 to 230v35
  31. Study sites: 227 to 229v34
  32. Study sites: 226 to 227v33
  33. Study sites: 222 to 226v32
  34. Study sites: 221 to 222v31
  35. Study sites: 220 to 221v30
  36. Study sites revised (220)v29 See this version in full on ClinicalTrials.gov ↗
  37. Study sites: 218 to 220v28
  38. Study sites: 215 to 218v27
  39. Study sites revised (215)v26 See this version in full on ClinicalTrials.gov ↗
  40. Study sites revised (215)v25 See this version in full on ClinicalTrials.gov ↗
  41. Study sites: 213 to 215v24
  42. Study sites revised (213)v23 See this version in full on ClinicalTrials.gov ↗
  43. Study sites: 208 to 213 Primary completion date: Oct 30, 2026 to Sep 21, 2026 · Completion date: Nov 6, 2026 to Oct 19, 2026v22 Show 2 more changesShow less
    • Primary completion date: Oct 30, 2026 to Sep 21, 2026
    • Completion date: Nov 6, 2026 to Oct 19, 2026
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
Trial Details
NCT Number NCT06585787
Lead Sponsor Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions Alzheimer Disease
Enrollment 406 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov