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

March 5, 2026 updated by: Eli Lilly and Company

Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease

The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N 5C8
        • Bruyere Research Institute
      • Peterborough, Ontario, Canada, K9H2P4
        • Kawartha Regional Memory Clinic
      • Toronto, Ontario, Canada, M3B2S7
        • Toronto Memory Program
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8J1
        • Clinique de la Memoire de l'Outaouais
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • DIEX Recherche Sherbrooke, Inc
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
      • Sun City, Arizona, United States, 85351
        • Banner Sun Health Research Institute
    • California
      • Fullerton, California, United States, 92835
        • Neurology Center of North Orange County
      • Irvine, California, United States, 92614
        • Irvine Clinical Research Center
      • Irvine, California, United States, 92697
        • Institute for Memory Impairment & Neurological Disorders
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • San Diego, California, United States, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, United States, 92103
        • Pacific Research Network Inc
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Associated Neurologists, PC - Danbury
      • Stamford, Connecticut, United States, 06905
        • KI Health Partners, LLC d/b/a NE Inst. for Clin. Res.
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Hollywood, Florida, United States, 33021
        • Infinity Clinical Research, LLC
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Merritt Island, Florida, United States, 32592
        • Merritt Island Medical Research LLC
      • Miami, Florida, United States, 33126
        • Pharmax Research Clinic
      • Miami, Florida, United States, 33137
        • Miami Jewish Health Systems
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Neurological Group
      • Pompano Beach, Florida, United States, 33064
        • Quantum Laboratories
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Sarasota, Florida, United States, 34239
        • Intercoastal Medical Group
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • Tampa, Florida, United States, 33609
        • Axiom Research
      • The Villages, Florida, United States, 32162
        • Compass Research
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology
    • Kansas
      • Fairway, Kansas, United States, 66160
        • University of Kansas Hospital
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinic
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research, Inc
      • Newton, Massachusetts, United States, 02459
        • Boston Center for Memory
      • Plymouth, Massachusetts, United States, 02360-4843
        • Donald S Marks
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Washington University
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Advanced Memory Research Institute of New Jersey
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Behavioral Health Center Research
      • Greensboro, North Carolina, United States, 27405
        • Guilford Neurologic Associates
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Insight Clinical Trials
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • Dayton, Ohio, United States, 45459
        • Neurology Diagnostics, Inc.
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington Neurological Associates
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • Texas
      • Dallas, Texas, United States, 75214
        • Texas Neurology, PA
      • Houston, Texas, United States, 77030
        • Houston Methodist
    • Vermont
      • Bennington, Vermont, United States, 05201
        • The Memory Clinic
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Cognition Health
      • Richmond, Virginia, United States, 23294
        • National Clinical Research - Richmond

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

56 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months.
  • MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.
  • Meet 18F flortaucipir PET scan eligibility criteria.
  • Meet 18F florbetapir PET scan (central read) eligibility criteria.

Exclusion Criteria:

  • Have a history of long QT syndrome.
  • Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.
  • Contraindication to MRI.

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 Monotherapy (Donanemab-M)
Participants received 700 milligram (mg) donanemab intravenously (IV) every 4 weeks (Q4W) x 3 doses, then 1400 mg donanemab IV Q4W for up to 72 weeks.
Drug: Donanemab
Administered IV
Other Names:
  • LY3002813
Placebo Comparator: Placebo
Participants received placebo IV Q4W for up to 72 weeks.
Drug: Placebo
Administered IV
Experimental: Donanemab in Combination With LY3202626 (Donanemab-C)

Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W in combination with 12 mg of LY3202626 orally for up to 72 weeks.

As per protocol amendment (d) approved on Oct 9, 2018, donanemab in combination with LY3202626 (donanemab-C) arm discontinued as there was a low probability of identifying a statistically significant effect of 12mg of LY3202626 slowing cognitive decline.
Drug: LY3202626
Administered orally
Drug: Donanemab
Administered IV
Other Names:
  • LY3002813

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Time Frame: Baseline, 76 Weeks
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates better performance. Least Squares (LS) Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, acetylcholinesterase inhibitor (AChEI) and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Baseline, 76 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score
Time Frame: Baseline, 76 Weeks
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Baseline, 76 Weeks
Change From Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score
Time Frame: Baseline, 76 Weeks
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Baseline, 76 Weeks
Change From Baseline in the Mini Mental State Examination (MMSE) Score
Time Frame: Baseline, 76 Weeks
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Baseline, 76 Weeks
Change From Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score
Time Frame: Baseline, 76 Weeks
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, pooled investigator, AChEI and/or memantine use at baseline, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Baseline, 76 Weeks
Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan
Time Frame: Baseline, 76 Weeks
Florbetapir PET imaging was used as a quantitative amyloid biomarker. Florbetapir PET scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in amyloid plaques. Quantitative amyloid burden was first formalized as the average Standardized Uptake Value Ratio (SUVR) in six predetermined cortical areas of the brain relative to the cerebellum as a reference region. Larger SUVR reflects the larger cortical amyloid burden relative to cerebellum. SUVR values were further calibrated to a centiloid (CL) scale. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. Least Squares mean change was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline, baseline-by-visit, and age at baseline.
Baseline, 76 Weeks
Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
Time Frame: Baseline, 76 Weeks
Flortaucipir PET imaging was used as a quantitative tau biomarker. Flortaucipir PET scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in aggregated tau neurofibrillary tangles (NFTs). Quantitative tau burden was formalized using two measures: weighted average Standardized Uptake Value Ratio (MUBADA SUVR) in the brain relative to the cerebellum gray as a reference region and the global tau load (TauL) generated using a TauIQ method. Larger weighted average SUVR reflects the larger cortical tau burden relative to cerebellum gray. The TauIQ method quantifies the spatiotemporal accumulation pattern of tau and larger TauL value reflects the larger global tau level in the brain as determined using a TauIQ mathematical framework. Least Squares mean change was controlled for baseline + age + treatment (Type III sum of squares).
Baseline, 76 Weeks
Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
Time Frame: Baseline, 76 Weeks
MRI scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in brain atrophy. Volumetric MRI (vMRI) parameters were measured in 14 brain regions: bilateral cortical, bilateral entorhinal cortex, bilateral hippocampus, bilateral inferior parietal lobe, bilateral isthmus cingulate, bilateral lateral parietal lobe, bilateral medial temporal lobe, bilateral precuneus, bilateral prefrontal lobe, bilateral superior temporal lobe, bilateral ventricles, bilateral whole brain, bilateral whole temporal lobe, and bilateral white matter. The atrophy was assessed by tensor-based morphometry, which captures volume changes within the deformation map. LS Mean value was controlled for fixed, categorical effects of treatment, visit and treatment-by-visit interaction, fixed covariates of baseline, and age at baseline.
Baseline, 76 Weeks

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 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)

December 18, 2017

Primary Completion (Actual)

December 4, 2020

Study Completion (Actual)

September 21, 2021

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16933 (IAEA)
  • I5T-MC-AACG (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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