Murea, Mariana
Gardezi, Ali I.
Goldman, Mathew P.
Hicks, Caitlin W.
Lee, Timmy
Middleton, John P.
Shingarev, Roman
Vachharajani, Tushar J.
Woo, Karen
Abdelnour, Lama M.
Bennett, Kyla M.
Geetha, Duvuru
Kirksey, Lee
Southerland, Kevin W
Young, Carlton J.
Brown, William M.
Bahnson, Judy
Chen, Haiying
Allon, Michael
Funding for this research was provided by:
National Institutes of Health (R01AG071803, R01AG071803)
Article History
Received: 9 January 2023
Accepted: 13 February 2023
First Online: 24 February 2023
Competing interests
: DG: consultant to ChemoCentryx, GSK, Aurinia Inc and Otsuka. CWH: speakers bureau for Cook Road Medical, W.G. Gore, and Silk Road Medical. JPM: advisory board member for Astra Zeneca and Vifor Inc. TL: consultant for BD Bard, Venostent, Inc, and Xeltis.
: This clinical study will be conducted in accordance with the Declaration of Helsinki. It will be conducted in compliance with the protocol, good clinical practice (GCP) (2001/20/EEC, CPMP/ICH/135/95), designated and local laws and regulations at each clinical center. This protocol, in its current version 4.4, has been approved by the central IRB of Wake Forest School of Medicine, and local IRB at each participating clinical center. During the study, all documents that are subject to review will be provided to the institutional ethics committees by the investigators in line with local and national regulatory provisions. Protocol amendments will be submitted for review and approval to the NIA Program Officer, DSMB and the concerned ethics committees in line with pertinent regulatory requirements. Written, informed consent will be obtained from all participants or Legally Authorized Representatives as detailed in the manuscript text. The central IRB has approved the initial protocol version and study documents on 12/16/2020. This first global amendment to the protocol also revised the informed consent and several study assessments to make answer selection more uniform for data analysis. The second global amendment to the protocol addressed protocol deviations and the timeline for administering the baseline questionnaires. The third global amendment revised the exclusion criteria by including the opinion of the site investigator on study eligibility of a candidate; and refined the cardiovascular conditions that deem a participant eligible for the study. With the fourth global amendment, age eligibility criteria for study participation was changed to ≥ 60 years; and recruitment sites were expanded by including an additional Healthcare System.
: Not applicable.
: MM has no competing interests. AIG has no competing interests. MPG has no competing interests. CWH: speakers bureau for Cook Road Medical, W.G. Gore, and Silk Road Medical. TL: consultant for BD Bard, Venostent, Inc, and Xeltis. JPM: advisory board member for Astra Zeneca and Vifor Inc. RS has no competing interests. TJV has no competing interests. KW has no competing interests. LMA has no competing interests. KMB has no competing interests. DG: consultant to ChemoCentryx, GSK, Aurinia Inc and Otsuka. LK has no competing interests. KWS has no competing interests. CJY has no competing interests. WMB has no competing interests. JB has no competing interests. HC has no competing interests. MA has no competing interests.