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Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 57 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 41 → 37 locationsv57
  2. Primary and study completion moved earlier from Jun 30, 2030 to Jul 31, 2027 Study sites revised (41)v56 Show 1 more changeShow less
    • Study sites revised (41)

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv55
  4. Enrollment target: estimated 285 to confirmed 241 Study sites: 44 to 41 · Eligibility criteria expanded, about 6 words · Secondary endpoints: details revised at 4 of 4 entries · 1 morev54 Show 4 more changesShow less
    • Study sites: 44 to 41
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study arms: 21 to 19

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion dates: Mar 31, 2028 to Jun 30, 2030v53
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 45 to 44v52
  2. Re-verified, no change to tracked fieldsv51
  3. Primary and study completion dates: Dec 31, 2027 to Mar 31, 2028v50
  4. Trial status: Recruiting to Active, Not Recruiting Study sites: 49 to 45v49 Show 1 more changeShow less
    • Study sites: 49 to 45
  5. Primary and study completion dates: Dec 31, 2028 to Dec 31, 2027v48
  6. Study sites: 50 to 49v47
  7. Primary and study completion dates: Sep 30, 2027 to Dec 31, 2028 Study sites: 49 to 50 · Eligibility criteria expanded, about 52 wordsv46 Show 2 more changesShow less
    • Study sites: 49 to 50
    • Eligibility criteria expanded, about 52 words

    See this version in full on ClinicalTrials.gov ↗

  8. Primary endpoints: 3 to 2 Enrollment target: 210 to 285 · Study sites: 48 to 49 · Secondary endpoints: details revised at 1 of 4 entries · 2 morev45 Show 5 more changesShow less
    • Enrollment target: 210 to 285
    • Study sites: 48 to 49
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study arms: 15 to 21
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 43 to 48v44
  10. Study sites: 35 to 43v43
  11. Study sites: 28 to 35v42
  12. Study sites: 22 to 28v41
  13. Study sites: 20 to 22v40
  14. Site details revised at 4 of 20 sitesv39
  15. Study sites: 18 to 20v38
  16. Enrollment target: 120 to 210 Primary and study completion dates: Jan 31, 2025 to Sep 30, 2027 · Study sites: 14 to 18 · Eligibility criteria expanded, about 181 words · 1 morev37 Show 4 more changesShow less
    • Primary and study completion dates: Jan 31, 2025 to Sep 30, 2027
    • Study sites: 14 to 18
    • Eligibility criteria expanded, about 181 words
    • Study arms: 8 to 15

    See this version in full on ClinicalTrials.gov ↗

  17. Site details revised at 1 of 14 sitesv36
  18. Re-verified, no change to tracked fieldsv35
  19. Site details revised at 1 of 14 sitesv34
  20. Site details revised at 1 of 14 sitesv33
  21. Eligibility criteria expanded, about 36 words Site details revised at 1 of 14 sitesv32 Show 1 more changeShow less
    • Site details revised at 1 of 14 sites

    See this version in full on ClinicalTrials.gov ↗

  22. Site details revised at 2 of 14 sitesv31
  23. Study sites revised (14)v30 See this version in full on ClinicalTrials.gov ↗
  24. Site details revised at 1 of 14 sitesv29
  25. Primary and study completion dates: Oct 3, 2024 to Jan 31, 2025v28
  26. Site details revised at 3 of 14 sitesv27
  27. Site details revised at 2 of 14 sitesv26
  28. Site details revised at 2 of 14 sitesv25
  29. Site details revised at 2 of 14 sitesv24
  30. Site details revised at 1 of 14 sitesv23
  31. Re-verified, no change to tracked fieldsv22
  32. Site details revised at 2 of 14 sitesv21
  33. Site details revised at 1 of 14 sitesv20
  34. Site details revised at 3 of 14 sitesv19
  35. Site details revised at 2 of 14 sitesv18
  36. Re-verified, no change to tracked fieldsv17
  37. Site details revised at 1 of 14 sitesv16
  38. Study Status, Eligibilityv15
  39. Re-verified, no change to tracked fieldsv14
  40. Site details revised at 1 of 14 sitesv13
  41. Site details revised at 1 of 14 sitesv12
  42. Site details revised at 1 of 14 sitesv11
  43. Re-verified, no change to tracked fieldsv10
  44. Site details revised at 1 of 14 sitesv9
  45. Site details revised at 2 of 14 sitesv8
  • 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 safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid positron emission tomography (PET) scan.
Trial Details
NCT Number NCT04639050
Lead Sponsor Hoffmann-La Roche
Conditions Alzheimers Disease
Enrollment 241 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov