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A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 3 of 154 sitesv33
  2. Site details revised at 2 of 154 sitesv32
  3. Study sites revised (154)v31 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 1 of 154 sitesv30
  5. Study sites revised (154)v29 See this version in full on ClinicalTrials.gov ↗
  6. Site details revised at 2 of 154 sitesv28
  7. Trial status changed: Active, Not Recruiting → Recruiting Trial sites expanded: 119 → 154 locations · Site details revised at 1 of 154 sitesv27 Show 2 more changesShow less
    • Trial sites expanded: 119 → 154 locations
    • Site details revised at 1 of 154 sites
  8. Trial status: Active, Not Recruiting to Recruiting Study sites: 119 to 154v26 Show 1 more changeShow less
    • Study sites: 119 to 154
  9. Study sites revised (119)v25 See this version in full on ClinicalTrials.gov ↗
  10. Sponsor changed: Karuna Therapeutics to Karuna Therapeutics, Inc., a Bristol Myers Squibb company Primary and study completion dates: Jul 31, 2025 to Dec 9, 2026 · Enrollment target: 400 to 500 · Eligibility criteria expanded, about 74 words · 2 morev24 Show 5 more changesShow less
    • Primary and study completion dates: Jul 31, 2025 to Dec 9, 2026
    • Enrollment target: 400 to 500
    • Eligibility criteria expanded, about 74 words
    • Secondary endpoints: 2 to 5
    • Site details revised at 1 of 119 sites

    See this version in full on ClinicalTrials.gov ↗

  11. Trial status: Recruiting to Active, Not Recruiting Study sites: 154 to 119v23 Show 1 more changeShow less
    • Study sites: 154 to 119
  12. Study sites revised (154)v22 See this version in full on ClinicalTrials.gov ↗
  13. Study sites revised (154)v21 See this version in full on ClinicalTrials.gov ↗
  14. Study sites revised (154)v20 See this version in full on ClinicalTrials.gov ↗
  15. Study sites revised (154)v19 See this version in full on ClinicalTrials.gov ↗
  16. Study sites revised (154)v18 See this version in full on ClinicalTrials.gov ↗
  17. Start date: Dec 23, 2023 to Aug 28, 2023 Study sites revised (154)v17 Show 1 more changeShow less
    • Study sites revised (154)

    See this version in full on ClinicalTrials.gov ↗

  18. Study sites revised (154)v16 See this version in full on ClinicalTrials.gov ↗
  19. Study sites: 153 to 154 Study title expanded, about 1 wordv15 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites revised (153)v14 See this version in full on ClinicalTrials.gov ↗
  21. Study sites revised (153)v13 See this version in full on ClinicalTrials.gov ↗
  22. Study sites: 150 to 153 Start date: Dec 26, 2023 to Dec 23, 2023v12 Show 1 more changeShow less
    • Start date: Dec 26, 2023 to Dec 23, 2023
  23. Study sites: 68 to 150 Primary and study completion dates: Jul 2025 to Jul 31, 2025v11 Show 1 more changeShow less
    • Primary and study completion dates: Jul 2025 to Jul 31, 2025
  24. Re-verified, no change to tracked fieldsv10
  25. Study sites: 64 to 68v9
  26. Study sites: 54 to 64v8
  27. Study sites: 45 to 54v7
  28. Study sites: 24 to 45v6
  29. Study sites: 21 to 24v5
  30. Start date changed from estimate of Dec 2023 to Dec 26, 2023v4
  31. Study sites: 18 to 21v3
  32. Study sites: 16 to 18 Start date: Nov 2023 to Dec 2023v2 Show 1 more changeShow less
    • Start date: Nov 2023 to Dec 2023
  33. 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, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Trial Details
NCT Number NCT06126224
Lead Sponsor Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions Psychosis Associated With Alzheimer's Disease
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov