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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders

In brief

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.

Key facts

Study ID

NCT05738486

Run by

Eli Lilly and Company

People needed

1175

Starts

2023-02-28

Expected to finish

2027-05-01

Last updated by the study team

2026-06-18

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Re:Cognition Health - London — London, London, City of, United Kingdom
• MD First Research - Chandler — Chandler, Arizona, United States
• Irvine Clinical Research — Irvine, California, United States
• Healthy Brain Clinic — Long Beach, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• JEM Research Institute — Atlantis, Florida, United States
• VIN-Julie Schwartzbard — Aventura, Florida, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• K2 Medical Research — Clermont, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
• Finlay Medical Research — Greenacres City, Florida, United States
• Infinity Clinical Research, LLC — Hollywood, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• ClinCloud - Maitland — Maitland, Florida, United States
• K2 Medical Research — Maitland, Florida, United States
• ClinCloud - Viera — Melbourne, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Charter Research - Winter Park — Orlando, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Alzheimer's Research and Treatment Center — Stuart, Florida, United States
• K2 Medical Research - Tampa — Tampa, Florida, United States
• K2 Summit Research — The Villages, Florida, United States
• Charter Research - Lady Lake — The Villages, Florida, United States

Full record on ClinicalTrials.gov

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