Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Cognitive, neuropsychological and biological effects of Oxygen-Ozone Therapy in frailty: a 5-week, randomized, placebo-controlled trial

Catia Scassellati
,
Cristian Bonvicini
* ORCID logo ,
Miriam Ciani
,
Roberta Zanardini
,
Evita Tomasoni
,
Valentina Saletti
,
Ilaria Passeggia
,
Monica Almici
ORCID logo ,
Ilaria Pagnoni
,
Antonio Carlo Galoforo
,
Mario Costa
,
Mara D’Onofrio
,
Antonino Cattaneo
,
Cristina Geroldi
Version 1 : Received: 18 March 2024 / Approved: 18 March 2024 / Online: 19 March 2024 (14:34:18 CET)

How to cite: Scassellati, C.; Bonvicini, C.; Ciani, M.; Zanardini, R.; Tomasoni, E.; Saletti, V.; Passeggia, I.; Almici, M.; Pagnoni, I.; Galoforo, A.C.; Costa, M.; D’Onofrio, M.; Cattaneo, A.; Geroldi, C. Cognitive, neuropsychological and biological effects of Oxygen-Ozone Therapy in frailty: a 5-week, randomized, placebo-controlled trial. Preprints 2024, 2024031069. https://doi.org/10.20944/preprints202403.1069.v1 Scassellati, C.; Bonvicini, C.; Ciani, M.; Zanardini, R.; Tomasoni, E.; Saletti, V.; Passeggia, I.; Almici, M.; Pagnoni, I.; Galoforo, A.C.; Costa, M.; D’Onofrio, M.; Cattaneo, A.; Geroldi, C. Cognitive, neuropsychological and biological effects of Oxygen-Ozone Therapy in frailty: a 5-week, randomized, placebo-controlled trial. Preprints 2024, 2024031069. https://doi.org/10.20944/preprints202403.1069.v1

Abstract

As the world’s population age, Cognitive Frailty (CF) is becoming one of the most serious health problems and elucidating its biological mechanisms along with prevention and treatments becomes increasingly important also considering the associated health costs. This pilot study aims to investigate the potential cognitive and neuropsychological effects of a 5-week treatment with a therapy based on the regenerative properties of ozone (O3) in a cohort of patients stratified according to CF. We also study the potential effects of O3 on blood-based biomarkers indicative of specific biological systems that may be altered in CF. Seventy-five older persons have been recruited and randomly assigned to receive the active treatment (150cc of oxygen-O2-O3 mixture at the concentration of 30ug of O3 per cc of O2) or O2, or the placebo (air) for 5 weeks. The primary endpoint is a change in the scores of clinical scales from baseline (T0) to weeks 3 (T3), 9 (T9), 15 (T15) after treatment. The secondary endpoint is a change in biomarkers levels resulting from transcriptomics, proteomics and metabolomic patterns at the same times. This study will evaluate whether an intervention with the O2-O3 therapy could have potential cognitive, neuropsychological and biological effects on CF.

Keywords

Cognitive frailty; frailty; randomized double blind clinical trial; oxygen-ozone therapy; neuropsychological markers; biological markers.

Subject

Biology and Life Sciences, Aging

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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