Effective as of June X, 2024
Data Use Agreement
This Data Use Agreement (“Agreement”) governs my request to access data, documentation, and analysis code collected by the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4)/Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) Study, hereafter (“Data Package”) for the purpose of scientific investigation, teaching or the planning of clinical research studies and agree to the following terms.
1. I understand I am being granted a one-time, non-exclusive, non-transferable license to the Data Package for the purposes specified in the data use application form and for no other purpose.
2. I will comply with all applicable federal, state, and local laws and regulations relating to data protection and the privacy of participant health information. I will only receive access to the Data Package which includes de-identified data and will not attempt to establish the identity of or attempt to contact any of the A4/LEARN participants. I will not combine the Data Package with other sources of data that would lead to the identification of any participant. I will not attempt to make direct contact with A4/LEARN investigators or staff at sites concerning the specific results of individual participants.
3. I will not further disclose the Data Package beyond the uses outlined in this Agreement and my data use application and understand that redistribution of the Data Package, beyond the permitted uses, in any manner is prohibited.
4. I will require anyone on my team who utilizes the Data Package to comply with the terms of this Agreement and the data use application.
5. I agree not to use AI tools, especially those with public-facing interfaces, that do not guarantee the security and confidentiality of data inputs and model weights related to A4/LEARN data. I understand that utilizing AI tools, including generative and analytical models, carries a potential risk of unintentional data disclosure due to how these tools store and process information that may result in data being sent, saved, viewed, or used in unforeseen ways by parties not covered by the DUA, which directly violates this agreement.
6. I will respond promptly and accurately to any requests to update this information.
7. I understand that this Agreement applies only to the A4/LEARN Data Package.
8. The Data Package shall not be commercialized.
If I publish abstracts using the Data Package, I agree to the following:
9. I will cite Alzheimer’s Clinical Trial Consortium A4/LEARN as the source of the Data Package and the A4/LEARN funding sources (National Institute on Aging/NIH, Eli Lilly and Co., Alzheimer’s Association, GHR Foundation, additional philanthropic donors) in the abstract as space allows.
If I publish manuscripts using the Data Package I agree to the following:
10. I will include the following acknowledgment statement:
The A4 Study was a secondary prevention trial in preclinical Alzheimer's disease, aiming to slow cognitive decline associated with brain amyloid accumulation in clinically normal older individuals. The A4 Study was funded by a public-private-philanthropic partnership, including funding from the National Institutes of Health-National Institute on Aging, Eli Lilly and Company, Alzheimer's Association, Accelerating Medicines Partnership, GHR Foundation, an anonymous foundation, and additional private donors, with in-kind support from Avid Radiopharmaceuticals, Cogstate, Albert Einstein College of Medicine and the Foundation for Neurologic Diseases.The companion observational Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) Study was funded by the Alzheimer's Association and GHR Foundation. The A4 and LEARN Studies were led by Dr. Reisa Sperling at Brigham and Women's Hospital, Harvard Medical School, and Dr. Paul Aisen at the Alzheimer's Therapeutic Research Institute (ATRI) at the University of Southern California. The A4 and LEARN Studies were coordinated by ATRI at the University of Southern California, and the data are made available under the auspices of Alzheimer’s Clinical Trial Consortium through the Global Research & Imaging Platform (GRIP). The complete A4 Study Team list is available on: . We would like to acknowledge the dedication of the study participants and their study partners who made the A4 and LEARN Studies possible.
11. If I become aware of any use or disclosure of the Data Package not provided for by this Agreement, I will report it within 48 hours of becoming aware of such use or disclosure.
12. I understand that the Data Package may be updated over time due to ongoing quality assurance processes.
13. This Agreement will continue for five (5) years from the data of submission (the “Term”). Upon expiration I will immediately cease using the Data Package and destroy or otherwise dispose of the Data Package.
I understand that failure to abide by these guidelines will result in termination of my privileges to access the A4/LEARN Data Package.