CO2 Exposure for Cognitive Impairment

Overseen By Alicia Legard

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Beta-blockers, Cns depressants

Disqualifiers: Cardiovascular disease, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to better understand the biological mechanisms of carbon dioxide (CO2)-induced cognitive impairments.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications for anxiety disorders, panic attacks, and those that may affect cognition, such as beta-blockers and CNS depressants. If you use sedating cold/allergy medications, marijuana, or alcohol, you must stop these for a specified period before participating.

How does CO2 exposure treatment differ from other treatments for cognitive impairment?

CO2 exposure treatment is unique because it involves controlled exposure to carbon dioxide, which is not a standard approach for cognitive impairment. Unlike traditional treatments that may focus on medication or lifestyle changes, this method explores the impact of CO2 levels on cognitive function, potentially offering insights into environmental factors affecting cognition. ^{1 2 3 4 5}

Who Is on the Research Team?

Howard Kipen, MD

Principal Investigator

Professor

Are You a Good Fit for This Trial?

This trial is for individuals who have been vaccinated against COVID-19 and weigh at least 110 pounds. It's not suitable for those with colorblindness, diabetes on insulin therapy, pregnant women, hearing impairments, recent asthma attacks, anxiety disorders or panic attacks treated with medication, cognitive-affecting medications like beta-blockers and CNS depressants, or a history of cardiovascular disease.

Inclusion Criteria

You have received a COVID-19 vaccine in the past.

You weigh at least 110 pounds.

Exclusion Criteria

Colorblindness

You are pregnant.

You have had an asthma attack within the past five years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exposure Sessions

Participants undergo two 2.5-hour exposure sessions with CO2 concentrations of either 600 ppm or 2500 ppm, at least one week apart. Neurobehavioral assessments and blood samples are collected.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after exposure sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbon Dioxide (CO2)

Trial Overview The study aims to understand how breathing in different levels of carbon dioxide (CO2) affects thinking abilities. Participants will be exposed to two CO2 concentrations: one similar to normal air (600 ppm) and another much higher (2500 ppm).

How Is the Trial Designed?

Group I: High CO2 Exposure first, then low CO2 exposure second. Experimental Treatment 2 Interventions

At the first study visit the subject is exposed to 2500 ppm CO2 for 2.5 hours and at the second study visit the subject is exposed to 600 ppm CO2 for 2.5 hours.

Group II: Low CO2 Exposure first, then high CO2 exposure second. Placebo Group 2 Interventions

At the first study visit the subject is exposed to 600 ppm CO2 for 2.5 hours and at the second study visit the subject is exposed to 2500 ppm CO2 for 2.5 hours.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

Mild cognitive impairment (MCI) affects 5% to 29% of the population, with significant variability in prevalence due to differences in case identification and sampling methods, highlighting the need for standardized definitions.

Key risk factors for MCI include age, education, race, hypertension, brain lesions, depression, and the presence of the APOE-4 allele, suggesting potential targets for future interventions to prevent progression to dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild cognitive impairment: an epidemiological perspective. Ritchie, K.[2022]

Using the recirculation (RC) setting in vehicles can effectively reduce exposure to roadway pollutants, but it can also lead to high levels of carbon dioxide (CO2) accumulation, especially during longer trips with multiple occupants.

While most average-duration commutes (about 26 minutes) for one or two occupants do not exceed the 2500 ppm CO2 threshold linked to cognitive effects, it's recommended to mix in outside air during longer trips or with more passengers to prevent reaching harmful CO2 levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon dioxide accumulation inside vehicles: The effect of ventilation and driving conditions. Hudda, N., Fruin, SA.[2018]

Exposure to air pollutants, particularly particulate matter (PM2.5 and PM10), is linked to cognitive disorders in the elderly, highlighting a significant public health concern.

Further research is needed, including large longitudinal studies and toxicological investigations, to better understand the physiological mechanisms behind the relationship between air pollution and cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Association between air pollution and cognitive function in the elderly]. Wang, JN., Wang, Q., Li, TT., et al.[2018]

The systematic review analyzed 1,551 abstracts and found that out of 10 articles, 8 met the criteria, indicating a potential association between historical air pollution exposure and poorer cognitive function in older adults.

While some studies suggested a link between air pollution and cognitive decline, the evidence was mixed for new cases of cognitive impairment, highlighting the need for more detailed and longitudinal research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is air pollution associated with increased risk of cognitive decline? A systematic review. Peters, R., Peters, J., Booth, A., et al.[2022]

In a study of 49,705 adults over nearly a decade, higher exposure to fine particulate matter (PM2.5) was linked to slower cognitive processing speeds, indicating a direct negative impact on cognitive function.

The research found that while lung function played a minor role in mediating the effects of PM2.5 on cognition, the majority of the cognitive impairment was due to direct exposure, highlighting the significant health risks posed by fine particles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term exposure to fine particulate matter, lung function and cognitive performance: A prospective Dutch cohort study on the underlying routes. Aretz, B., Janssen, F., Vonk, JM., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Mild cognitive impairment: an epidemiological perspective. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Carbon dioxide accumulation inside vehicles: The effect of ventilation and driving conditions. [2018]

3. China pubmed.ncbi.nlm.nih.gov

[Association between air pollution and cognitive function in the elderly]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Is air pollution associated with increased risk of cognitive decline? A systematic review. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term exposure to fine particulate matter, lung function and cognitive performance: A prospective Dutch cohort study on the underlying routes. [2021]