Active — Not RecruitingPhase 3

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

United States, United Kingdom1,175 participantsStarted 2023-02-28

Plain-language 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.

Who can participate

Age range

60 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically measuring how often participants develop ARIA-E, which is brain swelling or fluid buildup seen on imaging — how serious can that side effect be, and how would it be caught and managed if it happened to me?
2Since this is a Phase 3 trial comparing different dosing schedules of donanemab and it's no longer recruiting new participants, does that mean the results might be available soon, and should we wait to see those findings before deciding on a treatment path?
3The trial focuses on 'early' Alzheimer's disease — based on where I am in my diagnosis, would my doctor consider me to be at the right stage where a drug like donanemab is even being studied as potentially relevant?
4Given that the primary goal of this study is to understand ARIA-E rates across different doses rather than directly measuring memory or thinking improvements, what does that tell us about what stage of evidence donanemab is at in terms of proven benefit for patients like me?
5Are there currently approved treatments or other ongoing trials I should be weighing against what this trial is investigating, so I can understand all my options before committing to any one direction?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)

Timeframe: 24 Weeks

Trial details

NCT IDNCT05738486

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-16

Results submitted2025-05-16

View on ClinicalTrials.gov More Alzheimer's Disease trials