Zhou, Zhen
Webb, Katherine L.
Nelson, Mark R.
Woods, Robyn L.
Ernst, Michael E.
Murray, Anne M.
Chan, Andrew T.
Tonkin, Andrew
Reid, Christopher M.
Orchard, Suzanne G.
Kirpach, Brenda
Shah, Raj C.
Stocks, Nigel
Broder, Jonathan C.
Wolfe, Rory http://orcid.org/0000-0002-2126-1045
Article History
Received: 11 January 2024
Accepted: 1 July 2024
First Online: 29 July 2024
Declarations
:
: This post hoc analysis is exempt from ethics review because it uses existing data from ASPREE and ASPREE-XT, and no additional information was collected from participants. The ASPREE and ASPREE-XT studies were approved by local institutional review boards at each participating site, and all participants provided written informed consent for their participation. ASPREE-XT ethics approval in Australia is with Alfred Health Human Research Ethics Committee: HREC/17/Alfred/198 (Local Reference: Project 593/17). While in Australia, one consent covered the entirety of ASPREE-XT, in the USA, due to the transition to a single institutional review board (IRB) required for NIH multi-site research (NOT-OD-16–094) implemented in May 2017, two separate consent steps were employed—an initial 1-year consent for the XT01 visit which was approved under each individual sites’ IRB during the first year of transition from ASPREE to ASPREE-XT and a new consent for the subsequent 5 additional years of ASPREE-XT annual visits (XT02-XT06) approved under the single IRB of record (The University of Iowa).
: Not applicable.
: ZZ reported being funded through a National Heart Foundation Post-Doctoral Fellowship. MN reported receiving honoraria from Sanofi and Amgen as well as Bayer for materials in ASPREE and NHMRC grant support for STAREE. AT reported receiving research support or honoraria from Merck, Pfizer, and Amgen as well as Bayer for materials in the ASPREE trial and National Health and Medical Research Council (NHMRC) grant support for the Statins in Reducing Events in the Elderly (STAREE) trial. CR reported being funded through a National Health and Medical Research Council Principal Research Fellowship. RS serves as a non-compensated member of the Board of Directors of the Alzheimer’s Association –Illinois Chapter. RS’s institution, Rush University Medical Center, receives research support for his role as a site principal investigator or site sub-investigator for industry-initiated clinical trials and research studies of Alzheimer’s disease sponsored by Amylyx Pharmaceuticals, Inc, Eli Lilly & Co., Inc., Genentech, Inc., Lundbeck, Inc., Merck & Co., Inc., Navidea Biopharmaceuticals, Novartis Pharmaceuticals, Inc., Roche Holdings AG; and, Takeda Development Center Americas, Inc. He is also a member of the Steering Committee of the PREVENTABLE clinical trial. AC reports receiving research support or honoraria from Boehringer Ingelheim, Bayer Pharma AG, Pfizer Inc., Freenome, Zoe Ltd. for work unrelated to this manuscript. Others declare that they have no competing interests.