Document is current

Article History

Received: 24 May 2024

Accepted: 2 July 2024

First Online: 1 August 2024

Declarations

:

: We used the SPIRIT reporting guidelines to write this report []. The Cleveland Clinic Institutional Review Board (IRB) has approved this study protocol (current protocol approved 2/28/2024, v7). All significant protocol modifications are approved by the primary investigator and submitted to the Institutional Review Board for review and approval prior to being enacted. Given the healthy status of enrolled participants and the preventative, low risk nature of the intervention, no data monitoring committee has been established. Only participants who consent to hear about research findings and other research studies in the CCBS consent process are contacted regarding participation eligibility in the present study. Research coordinators for the MINDS study obtain informed consent from eligible participants in the MINDS study. Participant data for eligible and enrolled participants are collected and stored in a secure data registry. Trial conduct and documentation are audited by a quality assurance compliance officer independent from the study team and subject to IRB monitoring and approval. Results from the study analyses will be published in academic journals and shared with the sponsor. The sponsor can, in turn, share the results with the public.

: Not applicable.

: Vineet Punia is the PI of the MINDS study. He does not have any competing interests. Devon Conway has received research support paid to his institution from Biogen, Horizon, Bristol Myers Squibb, Novartis, EMD Serono and the Department of Defense. He has received consulting fees from Alexion, Bristol Myers Squibb, Novartis, and TG Therapeutics and speaking fees from Biogen. Robert Saper has received salary support from NIH for yoga-related studies and the Charles Shor Foundation. He has received royalties from UpToDate. Darlene Floden and Robyn Busch would like to disclose the potential for future distributions from Ceraxis Health, Inc. as inventors. The remaining authors have no competing interests to report.