A public resource of baseline data from the Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial.
A public resource of baseline data from the Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial.
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DOI：
10.1002/alz.12843
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发表时间：
2023-05
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The Alzheimer’s Prevention Initiative Autosomal Dominant Alzheimer’s Disease (API ADAD) Trial evaluated the anti-oligomeric amyloid-β (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. We developed mechanisms to share baseline data from the API ADAD Trial in consultation with experts and other groups sharing data from 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. Baseline demographic, PSEN1 E280A and APOE genotypes, florbetapir and FDG PET, MRI, clinical, and cognitive data can now be requested by interested researchers. 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 CAP 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.
