A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

May 22, 2026 updated by: Eli Lilly and Company

Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.

Approximately 375 additional participants will be enrolled in addendum 2.

Addendum 3 includes a subset of participants from the main study to receive a single dose.

The study will last approximately 91 weeks and include up to 26 visits in the main study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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 (Actual)

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.
1175

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: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B16 8LT
        • Re:Cognition Health - Birmingham
      • Plymouth, United Kingdom, PL6 8BT
        • Re:Cognition Health - Plymouth
    • Bristol, City of
      • Bristol, Bristol, City of, United Kingdom, BS32 4SY
        • Re:Cognition Health - Bristol
    • Hampshire
      • Winchester, Hampshire, United Kingdom, SO21 1HU
        • Re:Cognition Health - Winchester
    • London, City of
      • London, London, City of, United Kingdom, W1G 9JF
        • Re:Cognition Health - London
    • Reading
      • Guildford, Reading, United Kingdom, GU2 7YD
        • Re:Cognition Health Guildford
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85286
        • MD First Research - Chandler
    • California
      • Irvine, California, United States, 92614
        • Irvine Clinical Research
      • Long Beach, California, United States, 90804
        • Healthy Brain Clinic
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group, Inc.
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
      • Aventura, Florida, United States, 33180
        • VIN-Julie Schwartzbard
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials
      • Clermont, Florida, United States, 34711
        • K2 Medical Research
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Fort Myers, Florida, United States, 33912
        • Neuropsychiatric Research Center of Southwest Florida
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research
      • Hollywood, Florida, United States, 33024
        • Infinity Clinical Research, LLC
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Maitland, Florida, United States, 32751
        • K2 Medical Research
      • Maitland, Florida, United States, 32751
        • ClinCloud - Maitland
      • Melbourne, Florida, United States, 32940
        • ClinCloud - Viera
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Orlando, Florida, United States, 32803
        • Charter Research - Winter Park
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Stuart, Florida, United States, 34997
        • Alzheimer's Research and Treatment Center
      • Tampa, Florida, United States, 33607
        • K2 Medical Research - Tampa
      • The Villages, Florida, United States, 32159
        • K2 Summit Research
      • The Villages, Florida, United States, 32162
        • Charter Research - Lady Lake
      • Wellington, Florida, United States, 33414
        • Alzheimer's Research and Treatment Center
      • West Palm Beach, Florida, United States, 33407
        • Palm Beach Neurology
      • Winter Park, Florida, United States, 32789
        • Conquest Research
    • Georgia
      • Columbus, Georgia, United States, 31909
        • Columbus Memory Center, LLC
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch, LLC
      • Gainesville, Georgia, United States, 30501
        • Center for Advanced Research & Education
      • Savannah, Georgia, United States, 31405
        • CenExel iResearch, LLC
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
      • Watertown, Massachusetts, United States, 02472
        • Adams Clinical
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
    • New Jersey
      • Springfield, New Jersey, United States, 07081
        • The Cognitive and Research Center of New Jersey
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Neurology Clinic, P.C.
    • Texas
      • Beaumont, Texas, United States, 77702
        • Gadolin Research
      • Dallas, Texas, United States, 75231
        • Kerwin Medical Center
      • Houston, Texas, United States, 77054
        • The University of Texas Health Science Center at Houston
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Re:Cognition Health
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Tacoma, Washington, United States, 98405
        • Universal Research Group

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

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
  • A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.
  • Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology.

Exclusion Criteria:

  • Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures.
  • Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study.
  • A life expectancy of <24 months.
  • Contraindication to MRI or PET scans
  • Have had prior treatment with a passive anti-amyloid immunotherapy.
  • Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1.

Exceptions:

  • non-metastatic basal- or squamous-cell skin cancer
  • Stage 0 non-invasive carcinoma of the cervix
  • Stage 0 non-invasive prostate cancer, or
  • other cancers with low risk of recurrence or spread

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: 1400 mg Donanemab - Standard Regimen

Participants received:

  • 700 milligrams (mg) donanemab administered intravenously (IV) at baseline, week 4, and 8.
  • placebo administered IV at week 2, 6, 10, and 14.
  • 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.

Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose
Drug: Placebo
Administered IV
Drug: Donanemab
Administered IV
Other Names:
  • LY3002813
Experimental: 1400 mg Donanemab - Dose Skipping

Participants received:

  • 700 mg donanemab administered IV at baseline.
  • placebo administered IV at week 2, 4, 6, 10, and 14.
  • 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24.

Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose
Drug: Placebo
Administered IV
Drug: Donanemab
Administered IV
Other Names:
  • LY3002813
Experimental: 1400 mg Donanemab - Titration

Participants received:

  • 350 mg donanemab administered IV at baseline.
  • placebo administered IV at week 2, 6, 10, and 14.
  • 700 mg donanemab administered IV at week 4.
  • 1050 mg of donanemab administered IV at week 8.
  • 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.

Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose
Drug: Placebo
Administered IV
Drug: Donanemab
Administered IV
Other Names:
  • LY3002813
Experimental: 1400 mg Donanemab - Maximum Concentration (Cmax)

Participants received:

  • 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10.
  • 700 mg donanemab administered IV at weeks 12 and 14.
  • 1400 mg of donanemab administered IV at weeks 16, 20, and 24.

Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose
Drug: Placebo
Administered IV
Drug: Donanemab
Administered IV
Other Names:
  • LY3002813
Experimental: Donanemab Addendum 2 Arm 1

Participants will receive donanemab by IV infusion.

Participants will receive placebo pretreatment to preserve the blind prior to donanemab infusion.
Drug: Placebo
Administered IV
Drug: Donanemab
Administered IV
Other Names:
  • LY3002813
Experimental: Donanemab Addendum 2 Arm 2

Participants will receive donanemab by IV infusion.

Participants will receive dexamethasone pretreatment prior to donanemab infusion
Drug: Donanemab
Administered IV
Other Names:
  • LY3002813
Drug: Dexamethasone
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
Measure Description
Time Frame
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
Time Frame: 24 Weeks
Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.
24 Weeks

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
Measure Description
Time Frame
Percentage of Participants With Any Occurrence of ARIA-E
Time Frame: 52 Weeks
Outcome data will be provided after the study is completed.
52 Weeks
Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan
Time Frame: Baseline, 76 Weeks
Outcome data will be provided after the study is completed.
Baseline, 76 Weeks
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)
Time Frame: 24 Weeks
Percentage of participants with occurrence of ARIA-H at Week 24 is reported here.
24 Weeks
Percentage of Participants With ARIA-H
Time Frame: 52 Weeks
Outcome data will be provided after the study is completed.
52 Weeks
Percentage of Participants With Maximum Severity of ARIA-E or ARIA-H
Time Frame: 76 Weeks
Outcome data will be provided after the study is completed.
76 Weeks
Pharmacokinetics (PK): Average Serum Concentration of Donanemab
Time Frame: Baseline to 76 Weeks
Outcome data will be provided after the study is completed.
Baseline to 76 Weeks
Number of Participants With Anti-Drug Antibodies (ADAs) Against Donanemab, Including Treatment Emergent ADAs and Neutralizing Antibodies
Time Frame: Baseline to End of Follow-Up (91 Weeks)
Outcome data will be provided after the study is completed.
Baseline to End of Follow-Up (91 Weeks)

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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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.
February 28, 2023

Primary Completion (Actual)

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.
May 16, 2024

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.
May 1, 2027

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).
February 13, 2023

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.
February 13, 2023

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.
February 22, 2023

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.
June 18, 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.
May 22, 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.
October 1, 2025

More Information

Terms related to this study

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.
  • 18648
  • I5T-MC-AACQ (Other Identifier: Eli Lilly and Company)
  • 2022-502268-18-00 (Other Identifier: EU Trial Number)
  • U1111-1285-9438 (Other Identifier: UTN Number)

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 and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must 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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