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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 60 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Donanemab 		Participants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks
  • Drug: Donanemab
    Given IV
    Other names:
    • LY3002813
Placebo Comparator
Placebo 		Participants received placebo given IV.
  • Drug: Placebo
    Given IV

More Details

Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Study Contact

Detailed Description

TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of N3pG antibody (donanemab) in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain amyloid and tau pathology. Following the double-blind 76-week main study period, a double-blind 78-week long-term extension period is added to further evaluate donanemab efficacy and safety over time. Participants from the addendum safety cohort are not eligible for the extension period.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.