PRE-RANDOMIZATION DATA USE AGREEMENT
|I request access to pre-randomization study data
collected by the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease
(A4)/Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) Study
for the purpose of scientific investigation, teaching or the planning of clinical
research studies and agree to the following terms.
- I understand I am being granted a one-time, non-exclusive,
non-transferable license for use of anonymized, participant-level data
from the A4/LEARN study for the sole purpose of the request specified in
the data use application form and for no other purpose.
- 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 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 study data 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.
- I will not further disclose these data beyond the uses outlined in
this agreement and my data use application and understand that
redistribution of data, beyond the permitted uses, in any manner is prohibited.
- I will require anyone on my team who utilizes these data to comply
with this data use agreement and data use application.
- I will respond promptly and accurately to any requests to update this
- I will comply with any rules and regulations imposed by my institution
and its institutional review board in requesting these data.
- I understand that this data use agreement applies only to A4/LEARN
- The data will not be used as part of a filing with a regulatory
authority, whether for a marketing application or supplement or
investigational drug application.
If I publish abstracts using pre-randomization data from A4/LEARN, I agree
to the following:
- I will cite A4/LEARN as the source of data and the A4/LEARN funding
sources in the abstract as space allows.
If I publish manuscripts using data from A4/LEARN pre-randomization data,
I agree to the following:
- I will include the following acknowledgment statement:
The A4 Study is 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 is 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 and Cogstate. The companion observational Longitudinal
Evaluation of Amyloid Risk and Neurodegeneration (LEARN) Study is
funded by the Alzheimer's Association and GHR Foundation. The A4 and
LEARN Studies are 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), University of
Southern California. The A4 and LEARN Studies are coordinated by
ATRI at the University of Southern California, and the data are made
available through the Laboratory for Neuro Imaging at the University
of Southern California. The participants screening for the A4 Study
provided permission to share their de-identified data in order to
advance the quest to find a successful treatment for Alzheimer's
disease. We would like to acknowledge the dedication of all the
participants, the site personnel, and all of the partnership team
members who continue to make the A4 and LEARN Studies possible. The
complete A4 Study Team list is available on:
- If I become aware of any use or disclosure of the data not provided
for by this Agreement, I will report it within 48 hours of becoming
aware of such use or disclosure.
In the event that I download data from the A4/LEARN database for the
purposes of analysis and future publication in the form of abstracts and/or
- I will note the version of the data I download, and I will check the
database to determine if updated data has been provided prior to
submission of any material for publication.
- I understand that the data may be updated over time due to ongoing
quality assurance processes.
I understand that failure to abide by these guidelines will result in
termination of my privileges to access the A4/LEARN pre-randomization data.