Hyperbaric oxygen therapy for early Alzheimer's disease with vascular issues
Hyperbaric Oxygen Therapy for Prodromal Alzheimer´s Disease With Cerebrovascular Disease: A Prospective, Randomized, Double Blind Study
This study is testing if hyperbaric oxygen therapy can help improve thinking and memory in older adults with early Alzheimer's disease and blood flow issues in the brain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Locations | 1 site (Zerifin) |
| Trial ID | NCT05349318 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of hyperbaric oxygen therapy (HBOT) on patients with prodromal Alzheimer's disease characterized by mild cognitive impairment and cerebrovascular disease. It aims to improve neurological and cognitive functions by inducing neuroplasticity through a well-established treatment protocol. The study is designed as a prospective, randomized, sham-controlled, double-blinded trial involving 100 subjects aged 60-85, who will receive either HBOT or sham treatment over 60 sessions. Participants will be monitored for changes in cognitive function and overall health.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60-85 diagnosed with mild cognitive impairment due to Alzheimer's disease or mixed dementia with vascular components.
Not a fit: Patients with other neurodegenerative diseases or significant medical history that could interfere with the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this therapy could provide a novel approach to slowing the progression of Alzheimer's disease and improving cognitive function in affected patients.
How similar studies have performed: While hyperbaric oxygen therapy has shown promise in other conditions, its application in Alzheimer's disease is relatively novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zerifin
- Shamir Medical Center (Assaf Harofeh) — Zerifin, Israel (Recruiting)
Study contacts
- Principal investigator: Karin Elman Shina, MD — Senior Neurologist and director of the neuropsychology and physiology unit
- Study coordinator: Karin Elman Shina, MD
- Email: karine@shamir.gov.il
- Phone: 0097289778061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.