Hyperbaric Oxygen Therapy for Prodromal Alzheimer´s Disease With Cerebrovascular Disease

Launched by ASSAF-HAROFEH MEDICAL CENTER · Apr 24, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of Hyperbaric Oxygen Therapy (HBOT) to see if it can help people in the early stages of Alzheimer’s disease, specifically those who also have issues related to blood flow in the brain. Alzheimer's is a serious condition that affects memory and thinking, and currently, there are no medications that can stop its progression. The trial is looking for participants who have been diagnosed with mild cognitive impairment due to Alzheimer's or a mix of Alzheimer's and vascular dementia. To qualify, participants should have a score of 20 or higher on a memory test, have a caregiver who can help with the study, and be stable on their current treatments for at least three months.

Those who join the study can expect to receive hyperbaric oxygen treatment, which involves breathing pure oxygen in a pressurized room, and to participate in various assessments to track their cognitive health. However, there are specific criteria that might prevent someone from participating, such as having a history of certain brain injuries, severe health issues, or other neurological disorders. This study is currently recruiting participants, and it aims to find new ways to improve brain health for those at risk of developing Alzheimer's disease.

Gender

ALL

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