TRAILBLAZER-ALZ 2 (donanemab phase 3 trial imaging)
TRAILBLAZER-ALZ 2, a randomized placebo-controlled phase 3 trial of donanemab in early symptomatic Alzheimer disease (NCT04437511), trial MRI and PET
Serial safety MRI (FLAIR for ARIA-E, T2*-GRE for ARIA-H), volumetric MRI and amyloid and tau PET of 1736 people with early symptomatic Alzheimer disease in Lilly's donanemab phase 3 trial. The images are not shared; Lilly generally excludes MRI scans from its Vivli data sharing.
Overview
TRAILBLAZER-ALZ 2 is the phase 3 trial that tested donanemab, an antibody against deposited amyloid plaque, against placebo over 76 weeks in early symptomatic Alzheimer disease. Eli Lilly ran it at 277 centres in 8 countries and enrolled participants from June 2020 to November 2021. Its MRI captures amyloid-related imaging abnormalities (ARIA) as they emerge under treatment. This entry records what the publications say about the trial imaging. The images themselves are not available outside the sponsor.
Composition
1736 people were randomized, 860 to donanemab and 876 to placebo; 996 were women and the mean age was 73.0 years. All had amyloid and tau pathology on PET, 1182 with low or medium tau and 552 with high tau. 1320 completed the trial.
Acquisition
Eligibility used amyloid PET (florbetapir) and tau PET (flortaucipir), and MRI excluded people with ARIA-E, more than four microbleeds or other findings at screening. Safety MRI was repeated during treatment and whenever ARIA was suspected. The protocol names FLAIR as the sequence for ARIA-E and T2* gradient-recalled echo for ARIA-H; volumetric MRI was a secondary outcome. A scan four weeks after the first dose was added by amendment after serious ARIA was seen early in treatment. Scanner models and field strengths are not reported in the sources used here.
Annotations
A central MRI vendor chosen by Lilly read the scans for eligibility, ARIA-E and ARIA-H, and computed brain volumes. In the donanemab arm 205 participants (24.0%) had ARIA-E, 52 of them with symptoms, against 18 (2.1%) on placebo. No image-level labels are published.
Known limitations
- Lilly's Vivli policy states that it generally does not share MRI scans; tabular participant data may be requested through Vivli, but commercial use and AI-ML models for commercial products are refused.
- Participants were selected by amyloid and tau PET and screened to exclude more than four microbleeds or any macrohemorrhage, so people with a higher baseline haemorrhagic burden are absent.
- Field strength, vendors and sequence parameters are not published in the sources used here.
Cohort
Aggregate numbers from the sources below. Bars are relative to the 1,736 subjects.
Sex
- Female 996 100%
Covers 996 of 1,736 subjects.
Age
mean 73No age bins reported.
Condition
subjects, values can overlap
- Alzheimer's disease 1,736 100%
License and access
Our reading of the license, not legal advice. Before you use the data, read the original license and confirm that your use is allowed. We take no responsibility for how you use a dataset. Full disclaimer
The data are not available outside the institution or study that holds them
No published license or data use terms
The data holder has published no license and no data use terms. Any use, sharing or commercial right has to be agreed with the data holder, and nothing can be assumed to be allowed. Default copyright and data protection law still apply.
Lilly shares anonymized participant-level tabular data from this trial through Vivli after review of a research proposal and a signed data sharing agreement, but its Vivli member page states that "Lilly will generally not share case narratives, documentation for event adjudication, images (e.g., x-rays, MRI scans), genetic/genomic, or other "omic" data". The same page adds that "Data will not be provided to requestors where there is a potential conflict of interest, data is to be used for a commercial purpose or there is an actual or potential competitive risk" and "Data will not be provided to requestors to construct an AI-ML model that will serve as the foundation for a commercial product." No terms for the images are published.
What you can do
- Commercial use Not stated
- Train ML models Not stated
- Create derived data Not stated
- Publish results Not stated
What you can share
- Share the data Not stated
- Share derived data Not stated
- Share trained models Not stated
What you must do
- Cite or credit Not stated
- Share alike Not stated
- Sign an agreement Not stated
- Ethics approval Not stated
- Manuscript review Not stated
- Release code Not stated
- Return results Not stated
- Delete after use Not stated
Limits
- No re-identification Not stated
- Location limits Not stated
Citation
Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA 330(6):512-527 (2023). doi:10.1001/jama.2023.13239
All numbers
Every number on this page, as stored in stats.csv, with its source.
| Measure | Breakdown | Value | Source |
|---|---|---|---|
| Subjects | total randomized participants (860 donanemab and 876 placebo) | 1,736 | sims2023 Abstract (Results) |
| Subjects | sex=female | 996 | sims2023 Abstract (Results) |
| Subjects | condition=alzheimers all participants had early symptomatic Alzheimer disease (MCI or mild dementia) with amyloid and tau pathology on PET | 1,736 | sims2023 Abstract (Design and Participants) |
| Mean age | total | 73 | sims2023 Abstract (Results) |
Sources
The keys used in the table above.
- sims2023 Sims et al. 2023, JAMA, TRAILBLAZER-ALZ 2 primary results (PMC10352931) paper
- zimmer2025 Zimmer et al. 2025, JAMA Neurology, ARIA with donanemab in TRAILBLAZER-ALZ and ALZ 2 (PMC11894547), with the trial protocols and data sharing statement in its supplements paper
- ctgov-nct04437511 ClinicalTrials.gov record NCT04437511 website
- vivli-lilly Vivli member page, Lilly (data sharing policy) website