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NCT04437511 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Alzheimer Disease, sponsored by Eli Lilly and Company.

Active
Registry status
Phase 3
Development phase
1,736
Enrollment target
20
Study locations

NCT04437511 is a Phase 3 study of Alzheimer Disease that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 1,736 participants, below the 2,745-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT04437511, a Phase 3 study of Alzheimer Disease, is active but no longer recruiting, sponsored by Eli Lilly and Company.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,736 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Alzheimer Disease

Interventions

  • DRUG Placebo
  • DRUG Donanemab

Study Locations (20)

California

  • North County Neurology Associates - Carlsbad
  • Wr- Pri, Llc - Encino
  • Neuro-Pain Medical Center - Fresno
  • Neurology Center of North Orange County - Fullerton
  • Irvine Clinical Research - Irvine
  • Kaizen Brain Center - La Jolla
  • Senior Clinical Trials, Inc. - Laguna Hills
  • Collaborative Neuroscience Research, LLC - Los Alamitos
  • USC Keck School of Medicine - Los Angeles
  • Clinical Research Institute - Los Angeles
  • Neurovations - Napa
  • Hoag Memorial Hospital Presbyterian - Newport Beach

Arizona

  • Gilbert Neurology - Gilbert
  • Xenoscience - Phoenix
  • Banner Alzheimer's Institute - Phoenix
  • Perseverance Research Center - Scottsdale
  • Banner Sun Health Research Institute - Sun City
  • Banner Alzheimer's Institute Tucson - Tucson
  • Center for Neurosciences - Tucson

Arkansas

  • Health Initiatives Research - Fayetteville

Trial Details

FieldValue
Enrollment Target 1,736 participants
Start Date 2020-06-19
Est. Completion 2028-11
Phase Phase 3

Sponsor

Eli Lilly and Company

1,341 total trials

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What the Registry Record Tells You About NCT04437511

The ClinicalTrials.gov registry entry for NCT04437511 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,736 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,745-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (37% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04437511 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT04437511 about?

NCT04437511 is a clinical study titled "A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)". 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 dose...

What is the current status of trial NCT04437511?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,736 participants. The study started on 2020-06-19. Estimated completion is 2028-11.

What conditions does trial NCT04437511 study?

This clinical trial studies the following conditions: Alzheimer Disease.

What interventions are being tested in trial NCT04437511?

The interventions under investigation include: Placebo (DRUG), Donanemab (DRUG).

Who is sponsoring clinical trial NCT04437511?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04437511 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.