Xenon Gas Inhalation for Neuroinflammation

This study is testing the safety of xenon gas inhalation in healthy volunteers aged 55 to 75. Researchers want to see if xenon gas could eventually help people with neurodegenerative diseases like Alzheimer's. You would inhale xenon gas mixed with oxygen for different lengths of time (10, 20, 30, or 45 minutes). The main goal is to track any side effects you might have during and after treatment. This is an early-stage study, and xenon gas is not yet approved by the FDA, meaning it's only available through research studies like this one. There are 16 participants planned for this study.

Study design
This is an open-label study, meaning both you and the researchers will know which treatment group you are in. It involves 16 healthy participants, divided into four groups based on the duration of xenon gas inhalation.
What's involved
You would have a screening period of up to 7 days to check your eligibility. After treatment, you would have follow-up visits on days 1, 3, and 7. The maximum study duration for each person is 15 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety monitoring until 7 days after treatment.

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NCT06945614

Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation

Recruiting
PHASE1Ages 55–75InterventionalTreatment
General Biophysics LLC
~16 participants
Updated 2025-04-25 on ClinicalTrials.gov
What's tested:Xenon gas inhalation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Xenon Treatment-Related Adverse Events at Each Treatment Duration as Assessed by CTCAE v4.0
Measured over From treatment to the end of follow up at 7 days
Healthy Volunteer Study
1 sites across 1 states
Massachusetts1
  • Ilya Ilin, PhD · PRINCIPAL_INVESTIGATOR · General Biophysics
  • Howard L Weiner, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women"s Hospital

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  • Number of Participants with Xenon Treatment-Related Adverse Events at Each Treatment Duration as Assessed by CTCAE v4.0From treatment to the end of follow up at 7 days

    To determine the safety of xenon gas inhalation for 10, 20, 30, and 45 minutes in healthy volunteers. Investigators anticipate to observe no sedation, no nausea, and no vomiting. Measured Parameters for Safety Assessments during Xenon Administration (Intraoperative - every five (5) minutes): * Heart rate * Blood pressure * Respiratory rate * Body temperature * Peripheral blood oxygenation * Changes in capnometry * Electrocardiographic parameters and printed rhythm strip * Adverse events Depth of sedation will be assessed and recorded every five (5) minutes during Xenon Gas administration and upon completion of procedure and recovery, utilizing the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) by the anesthesiologist. Adverse events of special interest for this inhaled anesthetic: vomiting, hemodynamic changes requiring drug intervention, and sedation unresponsive to verbal commands. AEs will be assessed during repeated visits on day 1, day 3, and day 7.