AHEAD 3-45 screening data
AHEAD 3-45 Study (A3 and A45 trials of lecanemab in preclinical Alzheimer's disease), screening data
Screening data of the AHEAD 3-45 lecanemab prevention trials in cognitively unimpaired adults aged 55 to 80: 16,835 North American screens with amyloid PET imaging and cognitive testing. Post-randomization data are not shared.
Overview
AHEAD 3-45 is a public-private prevention study of the Alzheimer's Clinical Trials Consortium and Eisai that tests the anti-amyloid antibody lecanemab in cognitively unimpaired people. It runs two sister trials under one protocol with a shared screening process: A3 for people with intermediate brain amyloid (about 20 to 40 Centiloids) and A45 for people with elevated amyloid (above 40 Centiloids). The shared data cover the screening stage only and are meant for research on preclinical Alzheimer's disease, amyloid screening and recruitment.
Composition
The study started in July 2020 and finished enrolment in 2024 after 20,720 screens worldwide. The accessible dataset is limited to the 16,835 screens from sites in the United States and Canada, because of data sharing rules in other countries. Screening combined a blood test of the plasma amyloid-beta 42/40 ratio, cognitive testing and amyloid PET. The portal states that imaging data are available, but it does not list which scan types are included. Data after randomization are not shared.
Acquisition
About 100 sites in North America, Japan, Singapore, Australia and Europe took part, more than 70 of them in the US and Canada. Amyloid PET used only the tracer [18F]NAV4694 and tau PET only [18F]MK6240. MRI was used to check eligibility and to monitor amyloid-related imaging abnormalities during treatment; the design paper gives no sequence details.
Annotations
No image labels are described. Eligibility for A3 or A45 was decided from quantitative amyloid PET.
Known limitations
- Screening data only, and only from North American sites.
- The public pages do not list the image series, file formats, scanners or field strengths in the release.
- Participants were 55 to 80 years old at entry and cognitively unimpaired, and plasma prescreening screened out people unlikely to have elevated amyloid before they went on to PET.
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
A research proposal is reviewed and approved
AHEAD 3-45 Study Data Use Agreement
One-time, non-transferable license for an approved research proposal. No commercialization or redistribution, strict confidentiality and AI-tool safeguards, safety findings must be reported to Eisai within 24 hours, Eisai and USC get a license to any new invention and Eisai an option for an exclusive license, users from countries of concern are excluded, and the data must be destroyed after five years.
What you can do
- No
- Conditional
- Not stated
- Conditional
What you can share
- No
- Not stated
- Not stated
What you must do
- Yes
- Share alike No
- Yes
- No
- No
- Conditional
- Conditional
- Yes
Limits
- Yes
- Conditional
Commercial license: Not stated No commercial license offer is published; the agreement states the data package shall not be commercialized.
Citation
Rafii MS, Sperling RA, Donohue MC, et al. The AHEAD 3-45 Study: Design of a prevention trial for Alzheimer's disease. Alzheimer's & Dementia 19(4):1227-1233 (2023). doi:10.1002/alz.12748. The data use agreement also requires the AHEAD 3-45 acknowledgment statement.
All numbers
Every number on this page, as stored in stats.csv, with its source.
| Measure | Breakdown | Value | Source |
|---|---|---|---|
| Subjects | total reported as 16,835 screens from North American sites, the scope of the accessible dataset; whether repeat screens of one person are counted separately is not stated | 16,835 | ahead-portal Our Study |
| Minimum age | total eligibility age range | 55 | rafii2023 Abstract |
| Maximum age | total eligibility age range | 80 | rafii2023 Abstract |
Sources
The keys used in the table above.
- ahead-portal AHEAD 3-45 data portal home page (aheadstudydata.org) website
- rafii2023 Rafii et al. 2023, The AHEAD 3-45 Study design, Alzheimer's & Dementia (PMC full text) paper