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A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

Study acronym: ALTITUDE-AD
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: estimated 540 to confirmed 542 Study sites: 69 to 68v13 Show 1 more changeShow less
    • Study sites: 69 to 68
  2. Study sites: 93 to 69v12
  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 93 of 93 sitesv11 Show 1 more changeShow less
    • Site details revised at 93 of 93 sites
  4. Study sites revised (93)v10 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 9 of 93 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Phase: Phase 2/3 to Phase 2 Enrollment target: 2040 to 540 · Primary and study completion dates: Jan 2031 to Oct 2026 · Interventions: ACU193 (Drug), Placebo (Drug) to Placebo (Drug), sabirnetug (Drug) · 3 morev8 Show 6 more changesShow less
    • Enrollment target: 2040 to 540
    • Primary and study completion dates: Jan 2031 to Oct 2026
    • Interventions: ACU193 (Drug), Placebo (Drug) to Placebo (Drug), sabirnetug (Drug)
    • Secondary endpoints revised (32)
    • Site contacts updated at 8 of 93 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 109 to 93v7
  3. Study sites: 124 to 109v6
  4. Eligibility criteria shortened, about 2 wordsv5 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 9 of 124 sitesv4
  6. Study sites: 126 to 124v3
  7. Site details revised at 12 of 126 sitesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary purpose of this study is to evaluate the efficacy of sabirnetug infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.
Trial Details
NCT Number NCT06335173
Lead Sponsor Acumen Pharmaceuticals
Conditions Alzheimer Disease
Enrollment 542 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov