Inhaled xenon modulates microglia and ameliorates disease in mouse models of amyloidosis and tauopathy.
Wesley Brandao, Nimansha Jain, Zhuoran Yin...
https://pubmed.ncbi.nlm.nih.gov/39813317Actively Recruiting
Phase 1
Age: 55Years - 75Years
All Genders
Healthy Volunteers
ID06945614
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation in Healthy Adults Aged 55 to 75
Led by General Biophysics LLC · Updated on 2025-04-25
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
General Biophysics LLC
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of inhaling xenon gas in healthy volunteers to support its future use as a treatment for neurodegenerative diseases like Alzheimer's disease. This phase 1, open-label study aims to see if xenon gas can be safely inhaled without causing serious side effects. The study involves healthy adults aged 55 to 75 and is conducted at a single center. Participants receive xenon gas mixed with oxygen through an anesthesia face mask for one of four durations: 10, 20, 30, or 45 minutes. Before the xenon inhalation, they are given Zofran to help prevent side effects. The gas flow and concentration are carefully controlled and monitored by an anesthesiologist during treatment. After inhalation, pure oxygen is given for five minutes, followed by at least two hours of monitoring before discharge. The study includes five visits over about two weeks: a screening visit with physical exams, blood, urine, and ECG tests to confirm eligibility; a treatment visit for xenon gas inhalation; and three follow-up visits on days 1, 3, and 7 after treatment. At each visit, researchers will monitor vital signs, collect blood samples, and perform physical exams to assess safety and any treatment-related effects. After completing the study, participants return to their usual medical care providers.
CONDITIONS
Brief Title
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
Who Can Participate
Age: 55Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Male or female aged 55 to 75 years
- Good general health with no disease likely to interfere with study assessments
- Resting heart rate between 60 and 90 beats per minute with normal sinus rhythm
- Respiratory rate less than 14 breaths per minute
- Resting diastolic blood pressure between 60 and 90 mm Hg and systolic blood pressure between 110 and 140 mm Hg
- Peripheral blood oxygen saturation greater than 95%
- Immunizations fully up to date as assessed by primary care physician
- Negative pregnancy test for women of childbearing potential within 7 days prior to first dose
- Agreement to use two effective contraception methods during the study and for 90 days after
- Willingness to comply with all study requirements
- Adequate cognitive function to understand and sign consent form before procedures
You will not qualify if you...
- Body mass index greater than 30
- Flu-like syndrome or respiratory infection within 2 weeks prior to screening
- Active COVID-19 disease
- Pregnant, lactating, breastfeeding, or planning pregnancy during study
- Positive pregnancy test at screening or dosing day for women of childbearing potential
- History of unstable or unmanaged acute or chronic disease
- History of bradycardia, cardiac dysrhythmias, or use of beta blockers
- Cardiopulmonary diseases including pulmonary fibrosis, COPD, lung injury, pulmonary hypertension, or sleep apnea requiring CPAP
- Bowel obstruction, pneumocephalus, or conditions causing air pockets that may expand with xenon
- Medical conditions or medications causing delayed gastric emptying
- Known or potential difficult airway
- Inflammatory bowel disease, rheumatoid arthritis, lupus, asthma, thyroid disease, or type 1 diabetes
- Use of corticosteroids within one month prior to treatment
- History of cancer within 5 years except treated basal cell carcinoma
- Other medical conditions or abnormalities interfering with study participation as judged by investigator
- History of alcohol or substance abuse within past 2 years
- Clinically significant abnormal laboratory results at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 7 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 1 day
Participants receive xenon gas inhalation for 10, 20, 30, or 45 minutes under medical supervision, including monitoring of vital signs during and after administration.
1 treatment visit (in-person) with at least 2 hours of post-treatment monitoring
Follow-up
Duration - 7 days after treatment
Participants return for safety monitoring including blood tests, vital signs, physical exams, and ECG at 1, 3, and 7 days after treatment to assess health and treatment effects.
3 follow-up visits (in-person) on Days 1, 3, and 7 post-treatment
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here