# Hyperbaric oxygen therapy for cognition in diabetic elderly at high dementia risk

> **NIH NIH R01** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2020 · $796,424

## Abstract

Abstract
 This resubmission responds to “PAR-16-365-Pilot Clinical Trials for the Spectrum of Alzheimer’s Disease and
Age-related Cognitive Decline (R01)”. It will examine the efficacy of hyperbaric oxygen therapy (HBOT) in
improving cognitive functioning in cognitively impaired elderly with diabetes (T2D), who have high risk for
dementia. It is a collaboration of the Icahn School of Medicine at Mount Sinai, NY, the University of Wisconsin,
the Sagol Center for Hyperbaric Medicine and Research at Asaf Harofeh Medical Center, Israel—one of the
world’s largest and busiest hyperbaric units—and the Sheba Medical Center, Israel.
 HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at a pressure
above the ambient atmosphere. The combined action of hyperoxia and hyperbaric pressure leads to significant
improvements in tissue oxygenation, resulting in cerebrovascular benefits with improved ischemic damage and
cerebral blood flow. Recently, our group published compelling evidence from clinical trials indicating HBOT
neurotherapeutic effects in stroke, with better cognitive function and elevated brain activity in SPECT. New
preliminary data suggests potential neurotherapeutic effects of HBOT on T2D elderly with mild cognitive
impairment (MCI), showing better cognitive performance and brain activity.
 We propose a randomized controlled clinical trial examining the short (12 weeks) and long-term (12 months)
efficacy of HBOT. We will test hypotheses that HBOT compared to a sham condition improves cognitive
function and increases cerebral blood flow and glucose utilization in MCI patients with T2D. Such patients are
at high dementia risk and enriched in cerebrovascular disease, and thus have high potential for benefitting
from HBOT. Aim 1 examines the potential beneficial effects of HBOT on cognition (with a primary composite
measure of executive functions and episodic memory, both affected by T2D). Aim 2 examines effects of HBOT
on ischemic injury which will be measured by CBF at the level of capillaries in gray matter (by MRI arterial spin
labeling), and in macrovessels (by a novel 4D Flow MRI technology developed by our group). Aim 3 focuses
on effects of HBOT on cerebral glucose utilization using [F18]FDG-PET. Finally, Aim 4 investigates mediation
by the biomarkers, i.e. whether their inclusion in a mediation model will attenuate the effect of HBOT on
cognition, suggesting them as underlying mechanisms.
 This study will be performed in Israel, where there is optimal infrastructure and expertise for all the study
components at significantly lower costs. HBOT can be widely deployed in the US so if successful, this pilot
study will provide the basis for a multi-center large-scale clinical trial for definitive evidence of its benefits to
cognition in T2D patients at high dementia risk. Despite advances in our understanding of risk factors and the
pathologic basis for dementia, treatments are of very limited effects. As the...

## Key facts

- **NIH application ID:** 9697744
- **Project number:** 5R01AG051545-04
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** Mary Sano
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $796,424
- **Award type:** 5
- **Project period:** 2016-09-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9697744

## Citation

> US National Institutes of Health, RePORTER application 9697744, Hyperbaric oxygen therapy for cognition in diabetic elderly at high dementia risk (5R01AG051545-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9697744. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*