TY - JOUR
T1 - A public resource of baseline data from the Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial
AU - and the API ADAD Colombia Trial Group
AU - Reiman, Eric M.
AU - Pruzin, Jeremy J.
AU - Rios-Romenets, Silvia
AU - Brown, Chris
AU - Giraldo, Margarita
AU - Acosta-Baena, Natalia
AU - Tobon, Carlos
AU - Hu, Nan
AU - Chen, Yinghua
AU - Ghisays, Valentina
AU - Enos, Jessica
AU - Goradia, Dhruman D.
AU - Lee, Wendy
AU - Luo, Ji
AU - Malek-Ahmadi, Michael
AU - Protas, Hillary
AU - Thomas, Ronald G.
AU - Chen, Kewei
AU - Su, Yi
AU - Boker, Connie
AU - Mastroeni, Diego
AU - Alvarez, Sergio
AU - Quiroz, Yakeel T.
AU - Langbaum, Jessica B.
AU - Sink, Kaycee M.
AU - Lopera, Francisco
AU - Tariot, Pierre N.
N1 - Publisher Copyright:
© 2022 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.
PY - 2023/5
Y1 - 2023/5
N2 - Introduction: The Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease (API ADAD) Trial evaluated the anti-oligomeric amyloid beta (Aβ) antibody therapy crenezumab in cognitively unimpaired members of the Colombian presenilin 1 (PSEN1) E280A kindred. We report availability, methods employed to protect confidentiality and anonymity of participants, and process for requesting and accessing baseline data. Methods: We developed mechanisms to share baseline data from the API ADAD Trial in consultation with experts and other groups sharing data from Alzheimer's disease (AD) prevention trials, balancing the need to protect anonymity and trial integrity with making data broadly available to accelerate progress in the field. We pressure-tested deliberate and inadvertent potential threats under specific assumptions, employed a system to suppress or mask both direct and indirect identifying variables, limited and firewalled data managers, and put forth specific principles requisite to receive data. Results: Baseline demographic, PSEN1 E280A and apolipoprotein E genotypes, florbetapir and fluorodeoxyglucose positron emission tomography, magnetic resonance imaging, clinical, and cognitive data can now be requested by interested researchers. Discussion: Baseline data are publicly available; treatment data and biological samples, including baseline and treatment-related blood-based biomarker data will become available in accordance with our original trial agreement and subsequently developed Collaboration for Alzheimer's Prevention principles. Sharing of these data will allow exploration of important questions including the differential effects of initiating an investigational AD prevention therapy both before as well as after measurable Aβ plaque deposition.
AB - Introduction: The Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease (API ADAD) Trial evaluated the anti-oligomeric amyloid beta (Aβ) antibody therapy crenezumab in cognitively unimpaired members of the Colombian presenilin 1 (PSEN1) E280A kindred. We report availability, methods employed to protect confidentiality and anonymity of participants, and process for requesting and accessing baseline data. Methods: We developed mechanisms to share baseline data from the API ADAD Trial in consultation with experts and other groups sharing data from Alzheimer's disease (AD) prevention trials, balancing the need to protect anonymity and trial integrity with making data broadly available to accelerate progress in the field. We pressure-tested deliberate and inadvertent potential threats under specific assumptions, employed a system to suppress or mask both direct and indirect identifying variables, limited and firewalled data managers, and put forth specific principles requisite to receive data. Results: Baseline demographic, PSEN1 E280A and apolipoprotein E genotypes, florbetapir and fluorodeoxyglucose positron emission tomography, magnetic resonance imaging, clinical, and cognitive data can now be requested by interested researchers. Discussion: Baseline data are publicly available; treatment data and biological samples, including baseline and treatment-related blood-based biomarker data will become available in accordance with our original trial agreement and subsequently developed Collaboration for Alzheimer's Prevention principles. Sharing of these data will allow exploration of important questions including the differential effects of initiating an investigational AD prevention therapy both before as well as after measurable Aβ plaque deposition.
KW - Alzheimer's disease
KW - amyloid
KW - antibody
KW - data sharing
KW - magnetic resonance imaging
KW - positron emission tomography
KW - presenilin 1
KW - primary prevention
KW - secondary prevention
UR - http://www.scopus.com/inward/record.url?scp=85143266115&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85143266115&partnerID=8YFLogxK
U2 - 10.1002/alz.12843
DO - 10.1002/alz.12843
M3 - Article
C2 - 36373344
AN - SCOPUS:85143266115
SN - 1552-5260
VL - 19
SP - 1938
EP - 1946
JO - Alzheimer's and Dementia
JF - Alzheimer's and Dementia
IS - 5
ER -