Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT05349318
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Mild cognitive impairment (MCI) due to AD or mixed AD and vascular dementia pathology
2. MMSE score of 20 and above
3. Stable psychological and pharmacological treatment for more than three months prior to inclusion.
4. Caregiver that is seeing the patient at least twice per week and is willing to participate and accompany the patient and fill questionnaires
5. Subject willing and able to read, understand and sign an informed consent
Exclusion Criteria:
1. Inability to attend scheduled clinic visits and/or comply with the study protocol
2. History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy
3. Active malignancy
4. Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture
5. History of other neurodegenerative diseases including Parkinson's disease (PD), Lewy body dementia (LBD), Frontotemporal dementia (FTD), Multiple sclerosis (MS), Amyotrophic lateral sclerosis (ALS), Creutzfeld Jacob disease (CJD), Multisystem atrophy (MSA), Pseudobulbar palsy (PSP), Corticobasal degeneration (CBD), Wernicke Korsakoff syndrome
6. Chronic use of medications that may compromise cognitive function and cannot be stopped: Anticonvulsants, Anticholinergics, antiparkinsonian, corticosteroids, Benzodiazepines
7. Moderate to severe sleep apnea with no use of CPAP
8. Diagnosis of a psychiatric disorder including: major depression, schizophrenia, bipolar disorder
9. Serious suicidal ideation
10. Renal or liver insufficiency, electrolyte imbalances
11. Chronic heart failure with ejection fraction of 35 or less
12. HBOT for any reason prior to study enrolment
13. Chest pathology incompatible with pressure changes (including active asthma or COPD)
14. Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
15. An inability to perform an awake brain MRI or Amyloid PET
16. An inability to perform computerized cognitive tests (Neurotrax)
17. MMSE score below 20
18. No evidence of amyloid in the brain PET
19. No evidence of vascular related lesions in the brain MRI
20. Active smoking
21. Participation in another study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT05349318
Study Brief:
Protocol Section:
NCT05349318