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A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

NCT04437511

Active Not RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Alzheimer Disease

Interventions: Donanemab, Placebo

Countries: United States, Australia, Canada, Czechia, Japan, Netherlands, Poland, Puerto Rico

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.

Eligibility overview

Sex: ALL

Age: 60 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
* MMSE score of 20 to 28 (inclusive) at baseline
* Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
* Meet 18F florbetapir PET scan (central read) criteria
* Have a study partner who will provide written informed consent to participate

Exclusion Criteria:

* Contraindication to MRI or PET scans
* Current treatment with immunoglobulin G (IgG) therapy
Locations (274)
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Sun City, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Fayetteville, Arkansas, United States
  • Carlsbad, California, United States
  • Encino, California, United States
  • Fresno, California, United States
  • Fullerton, California, United States
  • Irvine, California, United States
  • La Jolla, California, United States
  • Laguna Hills, California, United States
  • Los Alamitos, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Napa, California, United States
  • Newport Beach, California, United States
  • Palo Alto, California, United States
  • Pasadena, California, United States
  • Poway, California, United States
  • Redlands, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • Santa Ana, California, United States
  • Sherman Oaks, California, United States
  • + 244 more on CT.gov