A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

May 15, 2026 updated by: Eli Lilly and Company

An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM

The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

550

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Puerto Rico
      • Bayamón, Puerto Rico, 00961
        • SCB Research Center
        • Principal Investigator:
          • William Julio
        • Contact:
          • Phone Number: (787) 798-4592
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
        • Contact:
          • Phone Number: 602-839-6900
        • Principal Investigator:
          • Po-Heng Tsai
    • California
      • Huntington Beach, California, United States, 92648
        • Care Access - Huntington Beach
        • Contact:
          • Phone Number: 714-378-2440
        • Principal Investigator:
          • Christine Thai
      • Irvine, California, United States, 92614
        • Irvine Clinical Research
        • Contact:
          • Phone Number: 9497531663
        • Principal Investigator:
          • Elly Lee
      • Long Beach, California, United States, 90804
        • Healthy Brain Clinic
        • Principal Investigator:
          • Dung Trinh
        • Contact:
          • Phone Number: 562-606-5999
      • Riverside, California, United States, 92503
        • Artemis Institute for Clinical Research
        • Contact:
          • Phone Number: 951-374-1190
        • Principal Investigator:
          • Jack Vu
      • Sacramento, California, United States, 95821
        • Clinical Trials Research
        • Principal Investigator:
          • Jeffrey Wayne
        • Contact:
          • Phone Number: 9164348230
      • San Diego, California, United States, 92123
        • Artemis Institute for Clinical Research
        • Principal Investigator:
          • Eric Chavez
        • Contact:
          • Phone Number: 8582783647
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
        • Contact:
          • Phone Number: 714-542-3008
        • Principal Investigator:
          • John Duffy
      • Santa Rosa, California, United States, 95403
        • Providence Medical Foundation
        • Principal Investigator:
          • Allan Bernstein
        • Contact:
          • Phone Number: 7075213830
      • Walnut Creek, California, United States, 94598
        • Infectious Disease Doctors Medical Group, APC
        • Principal Investigator:
          • Bhavna Malik
        • Contact:
          • Phone Number: 9259472334
    • Florida
      • Aventura, Florida, United States, 33180
        • VIN - Aventura
        • Contact:
          • Phone Number: 305-933-5993
        • Principal Investigator:
          • Jonathan Cross
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center, Inc.
        • Principal Investigator:
          • Eric Folkens
        • Contact:
          • Phone Number: 9417080005
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research
        • Principal Investigator:
          • Jorge Calle Medina
        • Contact:
          • Phone Number: 5617662181
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
        • Contact:
          • Phone Number: 904-730-0101
        • Principal Investigator:
          • Steven Toenjes
      • Maitland, Florida, United States, 32751
        • K2 Medical Research ORLANDO
        • Contact:
          • Phone Number: 407-500-5252
        • Principal Investigator:
          • Brandon Lenox
      • Merritt Island, Florida, United States, 32952
        • Merritt Island Medical Research, LLC
        • Principal Investigator:
          • David Kirk
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
        • Principal Investigator:
          • Lilia Rodriguez Ables
      • Miami, Florida, United States, 33133
        • VIN-Andrew Lerman
        • Principal Investigator:
          • Andrew Lerman
        • Contact:
          • Phone Number: 786-655-8010
      • Miami Lakes, Florida, United States, 33016
        • Indago Research & Health Center, Inc
        • Contact:
          • Phone Number: 3058256588
        • Principal Investigator:
          • Jose Cardona
      • Mt. Dora, Florida, United States, 32757
        • Adult Medicine of Lake County, Inc.
        • Principal Investigator:
          • Shirley Nagel
        • Contact:
          • Phone Number: 352-383-8222
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
        • Principal Investigator:
          • Cathy Barnes
        • Contact:
          • Phone Number: (727) 849-4131
      • Orlando, Florida, United States, 32803
        • Charter Research - Orlando
        • Principal Investigator:
          • Edgardo Rivera-Rivera
        • Contact:
          • Phone Number: 407-337-3000
      • Orlando, Florida, United States, 32803
        • Headlands Research Orlando
        • Principal Investigator:
          • Uzma Khan
        • Contact:
          • Phone Number: 1 (407) 705-3471
      • Pensacola, Florida, United States, 32504
        • Emerald Coast Neurology - Airport Boulevard
        • Principal Investigator:
          • David Bear
        • Contact:
          • Phone Number: 8504381136
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
        • Contact:
          • Phone Number: 386-304-7070
        • Principal Investigator:
          • Alexander White
      • Tampa, Florida, United States, 33625
        • Care Access - Tampa
        • Principal Investigator:
          • Brad Lipson
        • Contact:
          • Phone Number: 877-791-0656
      • Tampa, Florida, United States, 33634
        • K2 Medical Research - Tampa
        • Principal Investigator:
          • Kelley Wilson
        • Contact:
          • Phone Number: 813.800.5252
      • The Villages, Florida, United States, 32162
        • Charter Research - The Villages
        • Contact:
          • Phone Number: 352-441-2000
        • Principal Investigator:
          • Jeffrey Norton
      • Winter Park, Florida, United States, 32789
        • Conquest Research
        • Principal Investigator:
          • Rekha Gandhi
        • Contact:
          • Phone Number: 407-916-0060
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Center for Advanced Research & Education
        • Contact:
          • Phone Number: 7705345154
        • Principal Investigator:
          • Angela Ritter
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
        • Principal Investigator:
          • Bram Wieskopf
        • Contact:
          • Phone Number: 6784945735
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials
        • Contact:
          • Phone Number: 2086850600
        • Principal Investigator:
          • Brock McConnehey
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials - Andersonville
        • Principal Investigator:
          • Jeffrey Ross
        • Contact:
          • Phone Number: 7732753500
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology, PC
        • Principal Investigator:
          • Kristi George
        • Contact:
          • Phone Number: 3175376099
      • Indianapolis, Indiana, United States, 46254
        • Care Access - South Indianapolis
        • Principal Investigator:
          • Gigi Lefebvre
        • Contact:
          • Phone Number: 877-791-0656
    • Iowa
      • Waterloo, Iowa, United States, 50702
        • Covenant Medical Center
        • Principal Investigator:
          • NICHOLAS GOETSCH
        • Contact:
          • Phone Number: 3192722112
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Care Access - Lake Charles (Bayou Pines)
        • Principal Investigator:
          • Jason Morris
        • Contact:
          • Phone Number: 3376026642
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • Boston Center for Memory
        • Principal Investigator:
          • Paul Solomon
        • Contact:
          • Phone Number: 6176996927
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
        • Principal Investigator:
          • David DiBenedetto
        • Contact:
          • Phone Number: 6177441310
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Revival Research Institute, LLC
        • Principal Investigator:
          • Abdulhassan Saad
        • Contact:
          • Phone Number: 586-276-7453
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Citizens Memorial Hospital District
        • Contact:
          • Phone Number: 417-328-7781
        • Principal Investigator:
          • Curtis Schreiber
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Vector Clinical Trials
        • Principal Investigator:
          • Bharat Mocherla
        • Contact:
          • Phone Number: 702-750-000
    • New Jersey
      • Springfield, New Jersey, United States, 07081
        • The Cognitive and Research Center of New Jersey
        • Principal Investigator:
          • Raminder Parihar
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
        • Principal Investigator:
          • Awawu Igbinadolor
        • Contact:
          • Phone Number: 7042837359
    • Ohio
      • Dayton, Ohio, United States, 45459
        • NDx Clinical Research, Inc.
        • Principal Investigator:
          • Joel Vandersluis
        • Contact:
          • Phone Number: 937-224-8200
      • Lima, Ohio, United States, 45805
        • Care Access - Lima
        • Principal Investigator:
          • Gigi Lefebvre
        • Contact:
          • Phone Number: 877-791-0656
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research
        • Principal Investigator:
          • John Bertelson
        • Contact:
          • Phone Number: 5124078628
      • Beaumont, Texas, United States, 77702
        • Gadolin Research
        • Contact:
          • Phone Number: 409-331-6040
        • Principal Investigator:
          • Joseph Oommen
      • Houston, Texas, United States, 77054
        • The University of Texas Health Science Center at Houston
        • Contact:
          • Phone Number: 7134860536
        • Principal Investigator:
          • David Hunter
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
        • Contact:
          • Phone Number: 210-545-4900
        • Principal Investigator:
          • Michelle Welch
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
        • Principal Investigator:
          • Jeena Vaid
      • Tacoma, Washington, United States, 98405
        • Universal Research Group
        • Principal Investigator:
          • Sabrina Benjamin
        • Contact:
          • Phone Number: 253-882-1070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have completed study AACM Addendum 7.
  • Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
  • Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth.
  • Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  • Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study.
  • Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
  • Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution.
  • Contraindication to florbetapir F 18 PET.
  • Have had history of amyloid-targeting therapy treatment outside donanemab trials.
  • Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Donanemab
Donanemab administered intravenously (IV)
Drug: Donanemab
Administered IV
Placebo Comparator: Placebo
Placebo IV
Drug: Placebo
Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Time Frame: Baseline through Week 130
Baseline through Week 130

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline as Measured by Cognitive Function Index (CFI)
Time Frame: Baseline through Week 130
Baseline through Week 130
Change from Baseline in Brain Amyloid Plaque Levels as Measured by Florbetapir F 18 Positron Emission Tomography (PET) Scan.
Time Frame: Baseline through Week 130
Baseline through Week 130
Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)
Time Frame: Baseline through Week 130
Baseline through Week 130
Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab
Time Frame: Baseline, Week 52, Week 104
Baseline, Week 52, Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27890
  • I5T-MC-AACY (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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