This study is in progress, not accepting new patients

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

a study on Alzheimer's Disease Dementia

Summary

Eligibility
for people ages 60-85 (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

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.

Official Title

Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Details

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.

Participants previously dosed with donanemab in the main study will be monitored to track re-accumulation of amyloid plaque for 3 years.

Keywords

Alzheimer Disease, Alzheimer's, Dementia, Cognitive Impairment, Amyloid Plaque, Cognitive Dysfunction, donanemab, Counterfeit Drugs

Eligibility

You can join if…

Open to people ages 60-85

  • 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

You CAN'T join if...

  • Contraindication to MRI or PET scans
  • Current treatment with immunoglobulin G (IgG) therapy

Locations

  • UCSF Memory and Aging Center
    San Francisco 5391959 California 5332921 94158 United States
  • Kaizen Brain Center
    La Jolla 5363943 California 5332921 92037 United States
  • Irvine Clinical Research
    Irvine 5359777 California 5332921 92614 United States
  • Clinical Research Institute
    Los Angeles 5368361 California 5332921 90048 United States
  • Neuro-Pain Medical Center
    Fresno 5350937 California 5332921 93710 United States
  • Hoag Memorial Hospital Presbyterian
    Newport Beach 5376890 California 5332921 92663 United States
  • California Neuroscience Research Medical Group, Inc.
    Sherman Oaks 5395244 California 5332921 91403 United States
  • Tilda Research
    Tustin 5404119 California 5332921 92780 United States
  • Wr- Pri, Llc
    Encino 5346649 California 5332921 91316 United States
  • Sharp Neurocognitive Research Center
    San Diego 5391811 California 5332921 92123 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Donanemab (LY3002813) in Participants with Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
ID
NCT04437511
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1736 people participating
Last Updated