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ACP-204 in Adults With Alzheimer's Disease Psychosis

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 89 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 152 sites
  2. Study sites: 151 to 152
  3. Study sites: 150 to 151
  4. Study sites: 149 to 150
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 1 of 1 entry
  5. Study sites: 148 to 149v85
  6. Trial sites expanded: 145 → 148 locationsv84
  7. Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 3 of 145 sites
    v83
  8. Site details revised at 5 of 145 sitesv82
  9. Secondary endpoint revised
    • Site details revised at 42 of 145 sites
    v81
  10. Site details revised at 1 of 145 sitesv80
  11. Study sites: 143 to 145v79
  12. Site details revised at 2 of 143 sitesv78
  13. Site details revised at 11 of 143 sitesv77
  14. Study sites: 142 to 143v76
  15. Site details revised at 1 of 142 sitesv75
  16. Site details revised at 2 of 142 sitesv74
  17. Study sites: 141 to 142v73
  18. Study sites: 139 to 141v72
  19. Study sites: 137 to 139v71
  20. Study sites: 136 to 137v70
  21. Site details revised at 1 of 136 sitesv69
  22. Site details revised at 2 of 136 sitesv68
  23. Study sites: 134 to 136v67
  24. Site details revised at 1 of 134 sitesv66
  25. Study sites: 133 to 134v65
  26. Site details revised at 1 of 133 sitesv64
  27. Study sites: 132 to 133v63
  28. Study sites: 131 to 132v62
  29. Study sites: 130 to 131v61
  30. Study sites: 129 to 130v60
  31. Study sites: 127 to 129v59
  32. Study sites: 126 to 127v58
  33. Site details revised at 1 of 126 sitesv57
  34. Study sites: 125 to 126v56
  35. Study sites: 124 to 125v55
  36. Study sites: 123 to 124v54
  37. Study sites: 122 to 123v53
  38. Study sites: 120 to 122v52
  39. Site details revised at 1 of 120 sitesv51
  40. Study sites: 119 to 120v50
  41. Study sites: 117 to 119v49
  42. Study sites: 116 to 117v48
  43. Site details revised at 1 of 116 sitesv47
  44. Study sites: 115 to 116v46
  45. Study sites: 114 to 115v45
  46. Eligibility criteria expanded, about 12 words
    • Site details revised at 2 of 114 sites
    v44
  47. Study sites revised (114)v43
  48. Study sites: 113 to 114v42
  49. Study sites: 109 to 113v41
  50. Study sites: 107 to 109v40
  • 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 master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1. All 3 substudies will be analyzed independently of each other. Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
Trial Details
NCT Number NCT06159673
Lead Sponsor ACADIA Pharmaceuticals Inc.
Conditions
(from sponsor)		 Alzheimer's Disease Psychosis
Related terms Delusions, Hallucinations
Enrollment 1,074 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov