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Active, not recruiting Phase 3

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

NCT05738486 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2023-02-28
Last updated
2026-06-18

Condition(s) studied

Alzheimer's DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Investigational drug(s) / intervention(s)

Donanemab →PlaceboDexamethasone →

Donanemab: Administered IV

Placebo: Administered IV

Dexamethasone: Administered IV

Study summary

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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E) — 24 Weeks
    Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.

Trial sites (49)

FacilityCityRegionStatus
MD First Research - Chandler Chandler Arizona
Irvine Clinical Research Irvine California
Healthy Brain Clinic Long Beach California
California Neuroscience Research Medical Group, Inc. Sherman Oaks California
JEM Research Institute Atlantis Florida
VIN-Julie Schwartzbard Aventura Florida
Excel Medical Clinical Trials Boca Raton Florida
K2 Medical Research Clermont Florida
Brain Matters Research Delray Beach Florida
Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida
Finlay Medical Research Greenacres City Florida
Infinity Clinical Research, LLC Hollywood Florida
Jacksonville Center for Clinical Research Jacksonville Florida
ClinCloud - Maitland Maitland Florida
K2 Medical Research Maitland Florida
ClinCloud - Viera Melbourne Florida
Suncoast Clinical Research, Inc. New Port Richey Florida
Renstar Medical Research Ocala Florida
Charter Research - Winter Park Orlando Florida
Progressive Medical Research Port Orange Florida
Alzheimer's Research and Treatment Center Stuart Florida
K2 Medical Research - Tampa Tampa Florida
K2 Summit Research The Villages Florida
Charter Research - Lady Lake The Villages Florida
Alzheimer's Research and Treatment Center Wellington Florida
Palm Beach Neurology West Palm Beach Florida
Conquest Research Winter Park Florida
Columbus Memory Center, LLC Columbus Georgia
CenExel iResearch, LLC Decatur Georgia
Center for Advanced Research & Education Gainesville Georgia
CenExel iResearch, LLC Savannah Georgia
MedVadis Research Corporation Waltham Massachusetts
Adams Clinical Watertown Massachusetts
QUEST Research Institute Farmington Hills Michigan
The Cognitive and Research Center of New Jersey Springfield New Jersey
Butler Hospital Providence Rhode Island
Neurology Clinic, P.C. Cordova Tennessee
Gadolin Research Beaumont Texas
Kerwin Medical Center Dallas Texas
The University of Texas Health Science Center at Houston Houston Texas

+ 9 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05738486 on ClinicalTrials.gov ↗ ← All trials in the USA