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NCT07602582

A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 59 → 62 locations
    • Eligibility criteria expanded, about 10 words
  2. Study sites: 58 to 59v3
  3. Recruitment opened
    • Trial sites expanded: 53 → 58 locations
    • Study completion moved earlier from Dec 2029 to Sep 2029
    • Start date changed from estimate of May 2026 to May 22, 2026
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Timeframe: Baseline through Week 130

Secondary (4)

Change from Baseline as Measured by Cognitive Function Index (CFI)
Change from Baseline in Brain Amyloid Plaque Levels as Measured by Florbetapir F 18 Positron Emission Tomography (PET) Scan.
Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)
Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab

Arms and interventions

DonanemabExperimental

Donanemab administered intravenously (IV)

PlaceboPlacebo comparator

Placebo IV

Drugs: Donanemab, Placebo

Sites

62 sites in 3 countries

United States 55, Japan 6, Puerto Rico 1