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A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 17, 2026 (before its estimated October 5, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Karuna Therapeutics

Record History

The 50 most recent of 54 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Eligibility criteria expanded, about 26 words · Secondary endpoints: 18 to 19 · Study sites revised (129)v54 Show 3 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 18 to 19
    • Study sites revised (129)

    See this version in full on ClinicalTrials.gov ↗

  2. Trial sites expanded: 116 → 129 locationsv53
  3. Study sites revised (116)v52 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 1 of 116 sitesv51
  5. Sponsor changed: Karuna Therapeutics to Karuna Therapeutics, Inc., a Bristol Myers Squibb company Enrollment target: 380 to 410 · Eligibility criteria expanded, about 41 words · Secondary endpoints: 1 to 18 · 1 morev50 Show 4 more changesShow less
    • Enrollment target: 380 to 410
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: 1 to 18
    • Study sites revised (116)

    See this version in full on ClinicalTrials.gov ↗

Show 45 earlier versionsHide 45 earlier versions
  1. Site contacts updated at 1 of 116 sitesv49
  2. Study sites revised (116)v48 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (116)v47 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 2 of 116 sitesv46
  5. Eligibility criteria revised Study sites revised (116)v45 Show 1 more changeShow less
    • Study sites revised (116)

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites revised (116)v44 See this version in full on ClinicalTrials.gov ↗
  7. Study sites revised (116)v43 See this version in full on ClinicalTrials.gov ↗
  8. Study sites revised (116)v42 See this version in full on ClinicalTrials.gov ↗
  9. Study sites revised (116)v41 See this version in full on ClinicalTrials.gov ↗
  10. Study sites revised (116)v40 See this version in full on ClinicalTrials.gov ↗
  11. Study sites revised (116)v39 See this version in full on ClinicalTrials.gov ↗
  12. Study sites: 110 to 116v38
  13. Study sites revised (110)v37 See this version in full on ClinicalTrials.gov ↗
  14. Site contacts updated at 1 of 110 sites Study title expanded, about 1 wordv36 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  15. Study title shortened, about 1 wordv35 See this version in full on ClinicalTrials.gov ↗
  16. Study sites revised (110)v34 See this version in full on ClinicalTrials.gov ↗
  17. Study sites revised (110)v33 See this version in full on ClinicalTrials.gov ↗
  18. Primary completion date: Mar 31, 2025 to Oct 5, 2026 Study sites: 108 to 110 · Completion date: Apr 30, 2025 to Oct 5, 2026v32 Show 2 more changesShow less
    • Study sites: 108 to 110
    • Completion date: Apr 30, 2025 to Oct 5, 2026
  19. Study sites: 81 to 108 Primary completion date: Mar 2025 to Mar 31, 2025 · Completion date: Apr 2025 to Apr 30, 2025v31 Show 2 more changesShow less
    • Primary completion date: Mar 2025 to Mar 31, 2025
    • Completion date: Apr 2025 to Apr 30, 2025
  20. Re-verified, no change to tracked fieldsv30
  21. Study sites: 76 to 81v29
  22. Study sites: 74 to 76v28
  23. Study sites: 71 to 74v27
  24. Study sites: 70 to 71v26
  25. Study sites: 69 to 70v25
  26. Study sites: 67 to 69v24
  27. Study sites: 63 to 67v23
  28. Study sites: 60 to 63v22
  29. Study sites: 59 to 60v21
  30. Eligibility criteria expanded, about 103 words Study title shortened, about 1 wordv20 Show 1 more changeShow less
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  31. Study sites: 50 to 59v19
  32. Re-verified, no change to tracked fieldsv18
  33. Study sites: 49 to 50v17
  34. Study sites: 31 to 49v16
  35. Study sites: 25 to 31v15
  36. Study sites: 19 to 25v14
  37. Study sites: 13 to 19v13
  38. Re-verified, no change to tracked fieldsv12
  39. Study sites: 12 to 13v11
  40. Study sites: 10 to 12v10
  41. Study sites: 9 to 10v9
  42. Re-verified, no change to tracked fieldsv8
  43. Study sites: 7 to 9v7
  44. Site details revised at 5 of 7 sitesv6
  45. Re-verified, no change to tracked fieldsv5
  • 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.
This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.
Trial Details
NCT Number NCT05511363
Lead Sponsor Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions Psychosis Associated With Alzheimer's Disease
Enrollment 410 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov