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AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

StatusActive, Not Recruiting
PhasePhase 3
SponsorEisai Inc.
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites revised (107)v28 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 109 to 107v27
  3. Study arms: 6 to 5v26
  4. Trial status: Recruiting to Active, Not Recruiting Study sites: 117 to 109v25 Show 1 more changeShow less
    • Study sites: 117 to 109
  5. Study sites revised (117)v24 See this version in full on ClinicalTrials.gov ↗
Show 22 earlier versionsHide 22 earlier versions
  1. Study sites: 112 to 117 Primary completion date: Feb 15, 2029 to Dec 21, 2028 · Completion date: Feb 15, 2029 to Jan 16, 2031v23 Show 2 more changesShow less
    • Primary completion date: Feb 15, 2029 to Dec 21, 2028
    • Completion date: Feb 15, 2029 to Jan 16, 2031
  2. Primary and study completion dates: Oct 25, 2027 to Feb 15, 2029 Study sites: 111 to 112 · Eligibility criteria expanded, about 259 words · Study arms: 4 to 6v22 Show 3 more changesShow less
    • Study sites: 111 to 112
    • Eligibility criteria expanded, about 259 words
    • Study arms: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 6 of 111 sitesv21
  4. Study sites: 110 to 111v20
  5. Primary and study completion dates: Feb 15, 2029 to Oct 25, 2027v19
  6. Primary and study completion dates: Oct 25, 2027 to Feb 15, 2029 Site details revised at 1 of 110 sitesv18 Show 1 more changeShow less
    • Site details revised at 1 of 110 sites
  7. Re-verified, no change to tracked fieldsv17
  8. Study sites: 104 to 110v16
  9. Site details revised at 3 of 104 sitesv15
  10. Primary and study completion dates: May 28, 2027 to Oct 25, 2027 Eligibility criteria revisedv14 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  11. Primary and study completion dates: Oct 25, 2027 to May 28, 2027v13
  12. Study sites revised (104)v12 See this version in full on ClinicalTrials.gov ↗
  13. Site details revised at 1 of 104 sitesv11
  14. Start date: Jul 13, 2020 to Jul 14, 2020 Site details revised at 4 of 104 sitesv10 Show 1 more changeShow less
    • Site details revised at 4 of 104 sites
  15. Study sites: 102 to 104 Eligibility criteria shortened, about 12 wordsv9 Show 1 more changeShow less
    • Eligibility criteria shortened, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  16. Site details revised at 16 of 102 sitesv8
  17. Study sites: 103 to 102v7
  18. Study sites: 72 to 103 Eligibility criteria expanded, about 40 words · Secondary endpoints: details revised at 1 of 4 entriesv6 Show 2 more changesShow less
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 1 of 4 entries

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 3 to 72v5
  20. Interventions: BAN2401 (Drug), Placebo (Drug) to Lecanemab (Drug), Placebo (Drug) Eligibility criteria revised · Study title revisedv4 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  21. Re-verified, no change to tracked fieldsv3
  22. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3v2 Show 1 more changeShow less
    • Study sites: 0 to 3
  1. 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.
Biogen
92 trials monitored
See 7 trials at risk
Alzheimer's Disease
1,152 trials monitored
See 60 trials at risk
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.
Trial Details
NCT Number NCT04468659
Lead Sponsor Eisai Inc.
Collaborators: Alzheimer's Clinical Trials Consortium, Biogen, National Institute on Aging (NIA)
Conditions Preclinical Alzheimer's Disease, Early Preclinical Alzheimer's Disease
Enrollment 1,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov