A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Sponsor
Eli Lilly and Company
Study ID
NCT05508789
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Alzheimer Disease
  • Brain Diseases
  • Central Nervous System Diseases
  • Dementia
  • Mental Disorders
  • Nervous System Diseases
  • Neurocognitive Disorders
  • Neurodegenerative Diseases
  • Tauopathies

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Donanemab — DRUG
    Administered IV
  • Placebo — DRUG
    Administered IV

Study Details

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

Key Dates

Start date
Oct 10, 2022
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Donanemab
    Participants will receive donanemab intravenously (IV)
  • Placebo Comparator: Placebo
    Participants will receive placebo IV

Primary Outcome Measure

Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, Week 76 ]

Related Studies