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NCT05738486Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1175 (actual)
First submitted
13 Feb 2023
Start date
28 Feb 2023
Primary completion date
16 May 2024
Lead sponsor
Eli Lilly and Company
NCT number
NCT05738486
EU CT number
2022-502268-18-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1175
  • From 28 Feb 2023 to the primary completion date, 16 May 2024
  • 49 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have had prior treatment with a passive anti-amyloid immunotherapy.

Other illness

  • 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.
  • 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 prostate cancer, or
  • other cancers with low risk of recurrence or spread

Other

  • A life expectancy of \<24 months.
  • Contraindication to MRI or PET scans
  • Stage 0 non-invasive carcinoma of the cervix

Who the study is looking for

  • 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.

Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (49)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Re:Cognition Health - Birmingham
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BirminghamUnited KingdomUnknown status
Re:Cognition Health - Bristol
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BristolUnited KingdomUnknown status
Re:Cognition Health - Guildford
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GuildfordUnited KingdomUnknown status
Re:Cognition Health - London
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LondonUnited KingdomUnknown status
Re:Cognition Health - Plymouth
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PlymouthUnited KingdomUnknown status
Re:Cognition Health - Winchester
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WinchesterUnited KingdomUnknown status
JEM Research Institute
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AtlantisUnited StatesUnknown status
VIN-Julie Schwartzbard
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AventuraUnited StatesUnknown status
Gadolin Research
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BeaumontUnited StatesUnknown status
Northwest Clinical Research Center
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BellevueUnited StatesUnknown status
Excel Medical Clinical Trials
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Boca RatonUnited StatesUnknown status
MD First Research - Chandler
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ChandlerUnited StatesUnknown status
K2 Medical Research
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ClermontUnited StatesUnknown status
Columbus Memory Center, LLC
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ColumbusUnited StatesUnknown status
Neurology Clinic, P.C.
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CordovaUnited StatesUnknown status
Kerwin Medical Center
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DallasUnited StatesUnknown status
CenExel iResearch, LLC
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DecaturUnited StatesUnknown status
Brain Matters Research
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Delray BeachUnited StatesUnknown status
Re:Cognition Health
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FairfaxUnited StatesUnknown status
QUEST Research Institute
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Farmington HillsUnited StatesUnknown status
Neuropsychiatric Research Center of Southwest Florida
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Fort MyersUnited StatesUnknown status
Center for Advanced Research & Education
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GainesvilleUnited StatesUnknown status
Finlay Medical Research
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Greenacres CityUnited StatesUnknown status
Infinity Clinical Research, LLC
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HollywoodUnited StatesUnknown status
The University of Texas Health Science Center at Houston
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HoustonUnited StatesUnknown status
Irvine Clinical Research
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IrvineUnited StatesUnknown status
Jacksonville Center for Clinical Research
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JacksonvilleUnited StatesUnknown status
Healthy Brain Clinic
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Long BeachUnited StatesUnknown status
K2 Medical Research
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MaitlandUnited StatesUnknown status
ClinCloud - Maitland
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MaitlandUnited StatesUnknown status
ClinCloud - Viera
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MelbourneUnited StatesUnknown status
Suncoast Clinical Research, Inc.
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New Port RicheyUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
Charter Research - Winter Park
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OrlandoUnited StatesUnknown status
Progressive Medical Research
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Port OrangeUnited StatesUnknown status
Butler Hospital
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ProvidenceUnited StatesUnknown status
CenExel iResearch, LLC
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SavannahUnited StatesUnknown status
California Neuroscience Research Medical Group, Inc.
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Sherman OaksUnited StatesUnknown status
The Cognitive and Research Center of New Jersey
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SpringfieldUnited StatesUnknown status
Alzheimer's Research and Treatment Center
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StuartUnited StatesUnknown status
Universal Research Group
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TacomaUnited StatesUnknown status
K2 Medical Research - Tampa
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TampaUnited StatesUnknown status
Charter Research - Lady Lake
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The VillagesUnited StatesUnknown status
K2 Summit Research
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The VillagesUnited StatesUnknown status
MedVadis Research Corporation
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WalthamUnited StatesUnknown status
Adams Clinical
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WatertownUnited StatesUnknown status
Alzheimer's Research and Treatment Center
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WellingtonUnited StatesUnknown status
Palm Beach Neurology
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West Palm BeachUnited StatesUnknown status
Conquest Research
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Winter ParkUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.