Log in to access data
Effective as of October X, 2025

Data Use Agreement

AHEAD 3-45 Study

This Data Use Agreement ("Agreement") governs my request to access data, documentation, and analysis code collected by the A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study With an Extension Phase to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer's Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer's Disease and Intermediate Amyloid (A3 Trial), hereafter ("Data Package") for the purpose of scientific investigation, teaching or the planning of clinical research studies I agree to the following terms.

1. I understand I am being granted a one-time, non-exclusive, non-transferable license to access the Data Package for the sole purposes specified in the data use application form and for no other purpose ("hereinafter referred to as the "Research Proposal").

2. I, as well as any member of my research team, will comply with all applicable federal, state, and local laws and regulations, as well as applicable international data protection laws, including the General Data Protection Regulation (GDPR) relating to data protection and the privacy of participant health information. I will only receive access to the Data Package that has been de-identified using a comprehensive process, including:

  • Removal of site identifiers;
  • Masking of participant and study participant identifiers;
  • Removal of all free-text comment variables;
  • Replacement of dates with categorical visit identifiers and calculated days offsets from consent and randomization/baseline; and
  • Application of the Health Insurance Portability and Accountability Act (HIPAA) Safe Harbor method to all remaining variables.

These procedures follow the methods described in Jimenez-Maggiora (2024), (DOI: 10.14283/jpad.2024.120). I will not attempt to establish the identity of or attempt to contact any of the AHEAD 3-45 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 AHEAD 3-45 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 that any use of artificial intelligence (AI) tools, including generative, analytical, or large language models, in connection with the Data Package must be conducted in a manner that guarantees the security and confidentiality of data inputs and outputs. I will not use AI tools or platforms that transmit or process data through public-facing, cloud-hosted, or third-party systems unless those platforms:

  • Provide contractual assurances of confidentiality,
  • Do not use inputs or outputs for model training, product development or commercial purposes, and
  • The platform meets established standards for secure data handling of sensitive research data, including, at a minimum, data encryption, appropriate and reasonable access controls, and audit logging.

I understand that utilizing AI tools, including generative and analytical models, carries a potential risk of unintentional data disclosure. I understand that due to how these tools store and process information, data may be sent, saved, viewed, or used in unforeseen ways. I understand that it is my responsibility to prevent the misuse of data received under this agreement by conducting appropriate due diligence and only using secure systems. I further understand that I will be held responsible for data breaches or other misuse of data resulting from my decision to use AI to analyze the Data Package.

6. I will respond promptly and accurately to any requests to update the Data Package.

7. I understand that this Agreement applies only to the AHEAD 3-45 Data Package.

8. The Data Package shall not be commercialized.

9. I, along with any members of my research team agree to maintain strict confidentiality of the Data Package. Unauthorized disclosure, sharing, or use of the Data Package beyond the scope as described in the Research Proposal is strictly prohibited. The researcher shall implement appropriate administrative, technical, and physical safeguards to protect the confidentiality, integrity, and security of the Data Package, including protection against any anticipated threats or hazards and unauthorized access or disclosure. These safeguards should be consistent with the ISO/IEC 27001 standard for information security management, or equivalent institutional policies.

10. I represent and warrant that neither I, my institution, nor any member of my research team are a 'covered person' as defined under 28 CFR § 202, nor are we controlled by a 'country of concern' as defined therein. I further agree to notify the sponsor immediately should their status change with respect to these representations.

  • a. As of September 30, 2025, the countries of concern are China (including Hong Kong and Macau), Cuba, Iran, North Korea, Russia, and Venezuela.
  • b. As of September 30, 2025, covered persons are:
    • i. Non-US entities 50%+ owned by a country of concern
    • ii. Non-US entities 50%+ owned by another covered person
    • iii. Non-US entities organized or having a principal place of business in a county of concern
    • iv. Non-US employees or contractors of a country of concern or covered persons
    • v. Non-US individuals primarily resident in a county of concern
    • vi. Individuals or entities specifically identified as covered persons by the US Department of Justice at https://www.justice.gov/nsd

11. I agree to promptly notify both Eisai Inc. (the sponsor of the study) and ATRI at the University of Southern California in writing of any changes in majority or controlling minority ownership of the research entity, any engagement of material subcontractors or processors for the Data Package, or any material changes in data access practices that may affect the handling, security, or confidentiality of the Data Package. Such notification shall be made prior to the implementation of any such changes or as soon as reasonably practicable thereafter.

12. I agree to inform both Eisai Inc. and ATRI at the University of Southern California immediately, no later than within twenty-four (24) hours, of any information concluded from the research conducted pursuant to the Research Proposal that in the lead researcher's judgment could impact the risk-benefit assessment of Eisai's product (lecanemab), including but not limited to, any safety concerns, identified as part of the analysis. Eisai Inc's pharmacovigilance contact details are provided in Exhibit A. Eisai Inc. as the Study Sponsor or its affiliates may take action regarding such information, including informing regulatory authorities or healthcare providers, or otherwise making such information public, even in advance of publication of the Research Proposal. Promptly after a request, I shall provide access and reasonable assistance to Eisai Inc. to utilize and implement any analytical tools for the sole purpose of reproducing the Research Proposal.

13. I agree to promptly notify Eisai Inc. and ATRI at the University of Southern California in writing of any data breach involving the Data Package. Notification shall be made no later than forty-eight (48) hours after becoming aware of the breach and shall include a description of the nature of the breach, the data involved, and any remedial actions taken or planned. The researcher shall cooperate fully with the sponsor in investigating the breach, mitigating its effects, and complying with any applicable legal or regulatory requirements related to the breach.

14. Any new inventions that are conceived and first reduced to practice using the Data Package in the performance of the Research Proposal will be the sole property of the Researcher; however, the Researcher will promptly notify Eisai Inc. and University of Southern California in writing of any new inventions. Researcher's governing institution hereby grants to Eisai Inc. and University of Southern California a perpetual, non-exclusive, fully-paid up, royalty-free, worldwide, unrestricted license to use, perform, sublicense, and otherwise exploit any new invention in any manner and for any purpose, including commercial use, without limitation.

Researcher's governing institution shall further grant Eisai Inc. and its affiliates (as applicable), an option to negotiate an exclusive license to those new inventions, exercisable within sixty (60) days from notice of such new invention ("Election Period"). If Eisai Inc. or its affiliates timely notify the Researcher's governing institution that wishes to negotiate an exclusive license, Eisai Inc. or its affiliates and Researcher's governing institution will negotiate in good faith to reach an agreement on and execute a license agreement within ninety (90) days ("Negotiation Period") or such mutually agreeable longer period. In any such exclusive license, Researcher will reserve for itself, and other non-profit research institutions, a royalty-free, irrevocable license to make and use the new inventions for research, educational and clinical research purposes.

In the event that Eisai Inc. does not exercise its option to negotiate an exclusive license, during the Election Period or the parties fail to execute a license agreement prior to the end of the Negotiation Period, then Researcher's governing institution shall be free to exploit or license its interests in the new inventions without further obligation to Sponsor.

If I publish abstracts using the Data Package, I agree to the following:

15. I will cite Alzheimer's Clinical Trial Consortium AHEAD 3-45 as the source of the Data Package and the AHEAD 3-45 funding sources (National Institute on Aging/NIH, Eisai Inc., 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:

16. I will include the following acknowledgment statement: The AHEAD 3-45 is an ongoing secondary prevention trial in preclinical Alzheimer's disease, funded by a public-private-philanthropic partnership, including funding from the National Institutes of Health-National Institute on Aging, Eisai Inc., Alzheimer's Association, and the GHR Foundation. Eisai Inc. is the sponsor of The AHEAD 3-45 Study, which was conducted in partnership with Drs. Reisa Sperling and Keith Johnson 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 AHEAD 3-45 Study was 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 and Imaging Platform (GRIP). The complete AHEAD 3-45 Study Team list is available on: . We would like to acknowledge the dedication of the study participants and their study partners who made the AHEAD 3-45 Studies possible.

17. 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.

18. I understand that the Data Package may be updated over time due to ongoing quality assurance processes.

19. The Data Package is provided "AS IS" without warranty of any kind, express or implied, including warranties of accuracy, completeness, merchantability, fitness for a particular purpose, or non infringement.

20. I may not assign or transfer this Agreement (including by operation of law) without the prior written consent of Eisai Inc. and ATRI at the University of Southern California; any prohibited assignment is void.

21. This Agreement is governed by the laws of New York, without regard to conflicts of laws principles, and any permitted action shall be brought exclusively in the state or federal courts located in New York.

22. This Agreement will continue for five (5) years from the date of my acceptance of this Agreement (the "Term"). Upon expiration or earlier termination, I will immediately cease using the Data Package and destroy or otherwise dispose of the Data Package in accordance with ISO/IEC 27001 standards for secure data destruction or equivalent institutional policies. Upon request, I will provide written certification of destruction within thirty (30) days.

23. The obligations relating to confidentiality, data protection and safeguards, non identification, non redistribution, data breach notice and cooperation, safety reporting, IP ownership and licenses/options, publication acknowledgments, audit/verification, limitation of liability, and destruction/certification shall survive expiration or termination of this Agreement.

I understand that failure to abide by these guidelines will result in termination of my privileges to access the AHEAD 3-45 Data Package.

Exhibit A

To report an Adverse Event or Product Complaint, please contact:

Eisai Inc.

200 Metro Blvd.

Nutley, NJ 07110

(Tel) 1-888-274-2378 (Between the hours 8:30 AM through 5:00 PM EST)

Email: 

Eisai Inc has also developed an Information Portal to assist your Medical Information Needs: 

YOU MAY ALSO REPORT SUSPECTED ADVERSE EVENTS TO THE FDA BY CALLING 1-800-FDA-1088 OR BY CLICKING HERE:  

  • © 2026 ACTC. All rights reserved.
Data sharing enabled by the Global Research and Imaging Platform (GRIP) supported by GRP, LLC.