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Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 429 to 431 Eligibility criteria expanded, about 9 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 9 words
  2. Enrollment increased: 800 → 1000 participants Study sites: 428 to 429 · Eligibility criteria expanded, about 7 wordsv49 Show 2 more changesShow less
    • Study sites: 428 to 429
    • Eligibility criteria expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 426 to 428v48
  4. Trial sites expanded: 421 → 426 locationsv47
  5. Trial sites expanded: 416 → 421 locationsv46
  6. Study sites: 415 to 416v45
  7. Trial sites expanded: 412 → 415 locationsv44
  8. Sponsor changed: Karuna Therapeutics to Karuna Therapeutics, Inc., a Bristol Myers Squibb company Study sites revised (412)v43 Show 1 more changeShow less
    • Study sites revised (412)

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  9. Study sites revised (412)v42 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 411 to 412v41
  11. Interventions: KarX-EC (Drug), KarXT (Drug) to KarXT (Drug) Study sites revised (411) · Eligibility criteria shortened, about 3 words · Study title shortened, about 4 wordsv40 Show 3 more changesShow less
    • Study sites revised (411)
    • Eligibility criteria shortened, about 3 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 409 to 411v39
  13. Study sites: 397 to 409v38
  14. Study sites: 393 to 397v37
  15. Study sites: 392 to 393v36
  16. Study sites: 385 to 392v35
  17. Study sites: 383 to 385v34
  18. Enrollment target: 600 to 800 Interventions: KarXT (Drug) to KarX-EC (Drug), KarXT (Drug) · Eligibility criteria expanded, about 6 words · Study sites revised (383) · 1 morev33 Show 4 more changesShow less
    • Interventions: KarXT (Drug) to KarX-EC (Drug), KarXT (Drug)
    • Eligibility criteria expanded, about 6 words
    • Study sites revised (383)
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites revised (383)v32 See this version in full on ClinicalTrials.gov ↗
  20. Study sites: 381 to 383v31
  21. Study sites: 377 to 381v30
  22. Study sites revised (377)v29 See this version in full on ClinicalTrials.gov ↗
  23. Study sites revised (377)v28 See this version in full on ClinicalTrials.gov ↗
  24. Study sites: 373 to 377v27
  25. Study sites revised (373)v26 See this version in full on ClinicalTrials.gov ↗
  26. Study sites: 372 to 373v25
  27. Study sites: 366 to 372v24
  28. Study sites: 355 to 366v23
  29. Study sites: 330 to 355v22
  30. Study sites: 326 to 330v21
  31. Enrollment target: 300 to 600 Primary and study completion dates: Apr 30, 2026 to Sep 7, 2027 · Study sites: 280 to 326 · Eligibility criteria revisedv20 Show 3 more changesShow less
    • Primary and study completion dates: Apr 30, 2026 to Sep 7, 2027
    • Study sites: 280 to 326
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  32. Study sites: 255 to 280v19
  33. Study sites: 225 to 255v18
  34. Study sites: 209 to 225v17
  35. Study sites: 208 to 209 Start date: Aug 14, 2023 to Jul 11, 2023v16 Show 1 more changeShow less
    • Start date: Aug 14, 2023 to Jul 11, 2023
  36. Study sites revised (208)v15 See this version in full on ClinicalTrials.gov ↗
  37. Study sites revised (208)v14 See this version in full on ClinicalTrials.gov ↗
  38. Study sites revised (208)v13 See this version in full on ClinicalTrials.gov ↗
  39. Start date: Jul 11, 2023 to Aug 14, 2023 Study sites revised (208) · Study title expanded, about 1 wordv12 Show 2 more changesShow less
    • Study sites revised (208)
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  40. Study sites revised (208)v11 See this version in full on ClinicalTrials.gov ↗
  41. Trial status: Enrolling by Invitation to Recruiting Study sites: 198 to 208 · Completion date: May 31, 2026 to Apr 30, 2026v10 Show 2 more changesShow less
    • Study sites: 198 to 208
    • Completion date: May 31, 2026 to Apr 30, 2026
  42. Study sites: 12 to 198 Primary completion date: Apr 2026 to Apr 30, 2026 · Completion date: May 2026 to May 31, 2026 · Eligibility criteria revisedv9 Show 3 more changesShow less
    • Primary completion date: Apr 2026 to Apr 30, 2026
    • Completion date: May 2026 to May 31, 2026
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  43. Re-verified, no change to tracked fieldsv8
  44. Study sites: 7 to 12v7
  45. Study sites: 6 to 7v6
  46. Study sites: 3 to 6v5
  47. Study sites: 2 to 3v4
  48. Enrollment target: 140 to 300 Eligibility criteria expanded, about 6 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  49. Study sites: 1 to 2v2
  50. Study First Submitted
  • 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 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.
Trial Details
NCT Number NCT05980949
Lead Sponsor Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions Psychosis Associated With Alzheimer's Disease
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov