Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (Polaris-AD)

StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Study completion moved earlier from Dec 2027 to Oct 2027
    • Primary completion date changed from estimate of May 2026 to Jun 29, 2026
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints: 4 to 8
    • Site details revised at 7 of 198 sites
  2. Primary completion date: Dec 2025 to May 2026v46
  3. Study sites: 103 to 198v45
  4. Enrollment target: estimated 1150 to confirmed 1535v44
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 103 of 103 sites
    v43
Show 41 earlier versionsHide 41 earlier versions
  1. Study sites: 102 to 103v42
  2. Study sites revised (102)v41
  3. Study sites: 100 to 102v40
  4. Study sites: 96 to 100v39
  5. Study sites: 104 to 96v38
  6. Study sites revised (104)v37
  7. Study sites: 103 to 104v36
  8. Study sites: 102 to 103v35
  9. Site details revised at 98 of 102 sitesv34
  10. Study sites: 98 to 102v33
  11. Study sites: 84 to 98v32
  12. Study sites: 83 to 84v31
  13. Study sites: 75 to 83v30
  14. Study sites: 67 to 75v29
  15. Study sites: 57 to 67v28
  16. Study sites: 54 to 57v27
  17. Re-verified, no change to tracked fieldsv26
  18. Site details revised at 1 of 54 sitesv25
  19. Secondary endpoints: 5 to 4
    • Study description shortened, about 53 words
    v24
  20. Enrollment target: 800 to 1150
    • Eligibility criteria expanded, about 510 words
    v23
  21. Study sites: 49 to 54v22
  22. Study sites: 35 to 49v21
  23. Study sites: 28 to 35v20
  24. Study sites: 19 to 28v19
  25. Study sites: 17 to 19v18
  26. Study sites: 16 to 17v17
  27. Study sites: 9 to 16v16
  28. Study sites: 8 to 9v15
  29. Site contacts updated at 1 of 8 sitesv14
  30. Study sites: 7 to 8v13
  31. Study sites: 6 to 7v12
  32. Study title expanded, about 1 wordv11
  33. Study sites: 5 to 6v10
  34. Re-verified, no change to tracked fieldsv9
  35. Study sites: 4 to 5v8
  36. Study sites: 3 to 4v7
  37. Re-verified, no change to tracked fieldsv6
  38. Study sites: 1 to 3
    • Eligibility criteria shortened, about 356 words
    v5
  39. Start date changed from estimate of Dec 2022 to Dec 23, 2022v4
  40. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints: 6 to 5
  41. Primary completion date: Dec 2024 to Dec 2025v2 Show 6 more changesShow less
    • Enrollment target: 770 to 800
    • Study completion date: Jun 2027 to Dec 2027
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 9 to 6
    • Study description shortened, about 782 words
    • Study title expanded, about 4 words
  1. Study First Submitted
  • 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.
AriBio Co., Ltd.
1 trial monitored
See 1 trial at risk
Dementia
1,982 trials monitored
See 105 trials at risk
Alzheimer's Disease
1,255 trials monitored
See 68 trials at risk
This AR1001-ADP3-US01 protocol is a double-blind, randomized, placebo-controlled, multi- center, parallel-group comparison pivotal Phase 3 study to evaluate the efficacy and safety of AR1001 for the treatment of participants with early AD.
Trial Details
NCT Number NCT05531526
Lead Sponsor AriBio Co., Ltd.
Conditions
(from sponsor)		 Alzheimer Disease
Related terms Alzheimer Disease
Enrollment 1,535 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov