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A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

Study acronym: MINDSET 1
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 2 of 2 entries Eligibility criteria expanded, about 9 words · Secondary endpoints: details revised at 1 of 13 entries · Study sites revised (119) Show 3 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 13 entries
    • Study sites revised (119)
  2. Trial sites expanded: 116 → 119 locationsv21
  3. Trial sites expanded: 106 → 116 locationsv20
  4. Study sites revised (106)v19 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (106)v18 See this version in full on ClinicalTrials.gov ↗
  6. Trial sites reduced: 109 → 106 locationsv17
  7. Study sites: 111 to 109v16
  8. Study sites revised (111)v15 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 112 to 111v14
  10. Study sites revised (112)v13 See this version in full on ClinicalTrials.gov ↗
  11. Study sites revised (112)v12 See this version in full on ClinicalTrials.gov ↗
  12. Eligibility criteria expanded, about 24 words Study sites revised (112)v11 Show 1 more changeShow less
    • Study sites revised (112)

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites revised (112)v10 See this version in full on ClinicalTrials.gov ↗
  14. Study sites revised (112)v9 See this version in full on ClinicalTrials.gov ↗
  15. Study sites revised (112)v8 See this version in full on ClinicalTrials.gov ↗
  16. Study sites revised (112)v7 See this version in full on ClinicalTrials.gov ↗
  17. Study sites revised (112)v6 See this version in full on ClinicalTrials.gov ↗
  18. Study sites revised (112)v5 See this version in full on ClinicalTrials.gov ↗
  19. Study sites revised (112)v4 See this version in full on ClinicalTrials.gov ↗
  20. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 25, 2025 to Jul 14, 2025 · Study sites revised (112)v3 Show 2 more changesShow less
    • Start date changed from estimate of Jul 25, 2025 to Jul 14, 2025
    • Study sites revised (112)

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 113 to 112v2
  22. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Trial Details
NCT Number NCT06976216
Lead Sponsor Bristol-Myers Squibb
Conditions Alzheimer's Disease
Enrollment 586 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov