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

July 6, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

  • Japan
      • Chūōku, Japan, 103-0027
        • Not yet recruiting
        • Tokyo-Eki Center-building Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Arihiro Kiyosue
      • Hachiōji, Japan, 192-0071
        • Not yet recruiting
        • P-One Clinic
        • Principal Investigator:
          • Kenichi Furihata
        • Contact:
          • Phone Number: 81120023812
      • Shinjuku, Japan, 160-0017
        • Not yet recruiting
        • Samoncho Clinic
        • Principal Investigator:
          • takahiro yokoyama
        • Contact:
          • Phone Number: 81120023812
      • Shinjyuku, Japan, 160-0017
        • Not yet recruiting
        • Yotsuya Internal Medicine Clinic
        • Principal Investigator:
          • takahiro yokoyama
        • Contact:
          • Phone Number: 81120023812
      • tabashi City, Japan, 173-0015
        • Not yet recruiting
        • Tokyo Metropolitan Institute for Geriatrics and Gerontology
        • Principal Investigator:
          • Atsushi Iwata
        • Contact:
          • Phone Number: 81120023812
      • Ōbu, Japan, 474-8511
        • Not yet recruiting
        • National Center for Geriatrics and Gerontology
        • Principal Investigator:
          • MASASHI TSUJIMOTO
        • Contact:
          • Phone Number: 81120023812
  • Puerto Rico
      • Bayamón, Puerto Rico, 00961
        • Not yet recruiting
        • SCB Research Center
        • Principal Investigator:
          • William Julio
        • Contact:
          • Phone Number: (787) 798-4592
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Not yet recruiting
        • Banner Alzheimer's Institute
        • Contact:
          • Phone Number: 602-839-6900
        • Principal Investigator:
          • Po-Heng Tsai
    • California
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Care Access - Huntington Beach
        • Contact:
          • Phone Number: 714-378-2440
        • Principal Investigator:
          • Christine Thai
      • Irvine, California, United States, 92614
        • Recruiting
        • Irvine Clinical Research
        • Contact:
          • Phone Number: 949-753-1663
        • Principal Investigator:
          • Elly Lee
      • Long Beach, California, United States, 90804
        • Recruiting
        • Healthy Brain Clinic
        • Principal Investigator:
          • Dung Trinh
        • Contact:
          • Phone Number: 562-606-5999
      • Riverside, California, United States, 92503
        • Recruiting
        • Artemis Institute for Clinical Research
        • Contact:
          • Phone Number: 951-374-1190
        • Principal Investigator:
          • Jack Vu
      • Sacramento, California, United States, 95821
        • Recruiting
        • Clinical Trials Research
        • Principal Investigator:
          • Jeffrey Wayne
        • Contact:
          • Phone Number: 916-434-8230
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • Artemis Institute for Clinical Research
        • Contact:
          • Phone Number: 858-278-3647
        • Principal Investigator:
          • Eric Chavez
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Syrentis Clinical Research
        • Contact:
          • Phone Number: 714-542-3008
        • Principal Investigator:
          • John Duffy
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
        • Contact:
          • Phone Number: 707-521-3830
        • Principal Investigator:
          • Allan Bernstein
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Infectious Disease Doctors Medical Group, APC
        • Principal Investigator:
          • Bhavna Malik
        • Contact:
          • Phone Number: 925-947-2334
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • VIN - Aventura
        • Contact:
          • Phone Number: 305-933-5993
        • Principal Investigator:
          • Jonathan Cross
      • Bradenton, Florida, United States, 34205
        • Recruiting
        • Bradenton Research Center, Inc.
        • Principal Investigator:
          • Eric Folkens
        • Contact:
          • Phone Number: 941-708-0005
      • Greenacres City, Florida, United States, 33467
        • Recruiting
        • Finlay Medical Research
        • Contact:
          • Phone Number: 561-766-2181
        • Principal Investigator:
          • Jorge Calle Medina
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
        • Contact:
          • Phone Number: 904-730-0101
        • Principal Investigator:
          • Steven Toenjes
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research ORLANDO
        • Contact:
          • Phone Number: 407-500-5252
        • Principal Investigator:
          • Brandon Lenox
      • Merritt Island, Florida, United States, 32952
        • Recruiting
        • Merritt Island Medical Research, LLC
        • Principal Investigator:
          • David Kirk
      • Miami, Florida, United States, 33133
        • Recruiting
        • VIN-Andrew Lerman
        • Principal Investigator:
          • Andrew Lerman
        • Contact:
          • Phone Number: 786-655-8010
      • Miami, Florida, United States, 33126
        • Recruiting
        • Finlay Medical Research
        • Principal Investigator:
          • Lilia Rodriguez Ables
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Indago Research & Health Center, Inc
        • Principal Investigator:
          • Jose Cardona
        • Contact:
          • Phone Number: 305-825-6588
      • Mt. Dora, Florida, United States, 32757
        • Recruiting
        • Adult Medicine of Lake County, Inc.
        • Principal Investigator:
          • Shirley Nagel
        • Contact:
          • Phone Number: 352-383-8222
      • New Port Richey, Florida, United States, 34652
        • Recruiting
        • Suncoast Clinical Research, Inc.
        • Contact:
          • Phone Number: 727-849-4131
        • Principal Investigator:
          • Cathy Barnes
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Charter Research - Orlando
        • Principal Investigator:
          • Edgardo Rivera-Rivera
        • Contact:
          • Phone Number: 407-337-3000
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Headlands Research Orlando
        • Contact:
          • Phone Number: 407-705-3471
        • Principal Investigator:
          • Uzma Khan
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Emerald Coast Neurology - Airport Boulevard
        • Contact:
          • Phone Number: 850-438-1136
        • Principal Investigator:
          • David Bear
      • Port Orange, Florida, United States, 32127
        • Recruiting
        • Progressive Medical Research
        • Contact:
          • Phone Number: 386-304-7070
        • Principal Investigator:
          • Alexander White
      • Tampa, Florida, United States, 33625
        • Recruiting
        • Care Access - Tampa
        • Principal Investigator:
          • Brad Lipson
        • Contact:
          • Phone Number: 877-791-0656
      • Tampa, Florida, United States, 33634
        • Not yet recruiting
        • K2 Medical Research - Tampa
        • Contact:
          • Phone Number: 813-800-5252
        • Principal Investigator:
          • Kelley Wilson
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research - The Villages
        • Contact:
          • Phone Number: 352-441-2000
        • Principal Investigator:
          • Jeffrey Norton
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research
        • Principal Investigator:
          • Rekha Gandhi
        • Contact:
          • Phone Number: 407-916-0060
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Center for Advanced Research & Education
        • Principal Investigator:
          • Angela Ritter
        • Contact:
          • Phone Number: 770-534-5154
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • North Georgia Clinical Research
        • Contact:
          • Phone Number: 678-494-5735
        • Principal Investigator:
          • Bram Wieskopf
    • Idaho
      • Boise, Idaho, United States, 83704
        • Recruiting
        • Northwest Clinical Trials
        • Contact:
          • Phone Number: 208-685-0600
        • Principal Investigator:
          • Brock McConnehey
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Great Lakes Clinical Trials - Andersonville
        • Contact:
          • Phone Number: 773-275-3500
        • Principal Investigator:
          • Jeffrey Ross
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Josephson Wallack Munshower Neurology, PC
        • Principal Investigator:
          • Kristi George
        • Contact:
          • Phone Number: 317-537-6099
      • Indianapolis, Indiana, United States, 46254
        • Recruiting
        • Care Access - South Indianapolis
        • Principal Investigator:
          • Gigi Lefebvre
        • Contact:
          • Phone Number: 877-791-0656
    • Iowa
      • Waterloo, Iowa, United States, 50702
        • Not yet recruiting
        • Covenant Medical Center
        • Principal Investigator:
          • NICHOLAS GOETSCH
        • Contact:
          • Phone Number: 319-272-2112
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Recruiting
        • Care Access - Lake Charles (Bayou Pines)
        • Principal Investigator:
          • Jason Morris
        • Contact:
          • Phone Number: 337-602-6642
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • Recruiting
        • Boston Center for Memory
        • Contact:
          • Phone Number: 617-699-6927
        • Principal Investigator:
          • Paul Solomon
      • Waltham, Massachusetts, United States, 02451
        • Not yet recruiting
        • MedVadis Research Corporation
        • Contact:
          • Phone Number: 617-744-1310
        • Principal Investigator:
          • David DiBenedetto
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Not yet recruiting
        • Revival Research Institute, LLC
        • Principal Investigator:
          • Abdulhassan Saad
        • Contact:
          • Phone Number: 586-276-7453
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Citizens Memorial Hospital District
        • Contact:
          • Phone Number: 417-328-7781
        • Principal Investigator:
          • Curtis Schreiber
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Vector Clinical Trials
        • Principal Investigator:
          • Bharat Mocherla
        • Contact:
          • Phone Number: 702-750-000
    • New Jersey
      • Springfield, New Jersey, United States, 07081
        • Recruiting
        • The Cognitive and Research Center of New Jersey
        • Principal Investigator:
          • Raminder Parihar
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Not yet recruiting
        • Monroe Biomedical Research
        • Principal Investigator:
          • Awawu Igbinadolor
        • Contact:
          • Phone Number: 704-283-7359
    • Ohio
      • Dayton, Ohio, United States, 45459
        • Not yet recruiting
        • NDx Clinical Research, Inc.
        • Principal Investigator:
          • Joel Vandersluis
        • Contact:
          • Phone Number: 937-224-8200
      • Lima, Ohio, United States, 45805
        • Recruiting
        • Care Access - Lima
        • Principal Investigator:
          • Gigi Lefebvre
        • Contact:
          • Phone Number: 877-791-0656
    • Texas
      • Austin, Texas, United States, 78757
        • Not yet recruiting
        • Senior Adults Specialty Research
        • Contact:
          • Phone Number: 512-407-8628
        • Principal Investigator:
          • John Bertelson
      • Beaumont, Texas, United States, 77702
        • Recruiting
        • Gadolin Research
        • Contact:
          • Phone Number: 409-331-6040
        • Principal Investigator:
          • Joseph Oommen
      • Houston, Texas, United States, 77054
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
          • Phone Number: 713-486-0536
        • Principal Investigator:
          • David Hunter
      • Shavano Park, Texas, United States, 78231
        • Not yet recruiting
        • Consano Clinical Research, LLC
        • Contact:
          • Phone Number: 210-545-4900
        • Principal Investigator:
          • Michelle Welch
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Principal Investigator:
          • Jeena Vaid
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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