Status:
RECRUITING
Hyperbaric Oxygen Therapy for Prodromal Alzheimer´s Disease With Cerebrovascular Disease
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Prodromal Alzheimer's Disease
Cerebral Vascular Disorder
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
Alzheimer´s disease is a devastating illness that effects the patients as well as their family members. Its prevalence increases exponentially and the burden on the healthcare system is enormous. AD n...
Detailed Description
Alzheimer disease is characterised by cognitive, mental and functional disability that is expected to progress until the patient is fully dependent on others for activities of daily living. The pathol...
Eligibility Criteria
Inclusion
- Diagnosis of Mild cognitive impairment (MCI) due to AD or mixed AD and vascular dementia pathology
- MMSE score of 20 and above
- Stable psychological and pharmacological treatment for more than three months prior to inclusion.
- Caregiver that is seeing the patient at least twice per week and is willing to participate and accompany the patient and fill questionnaires
- Subject willing and able to read, understand and sign an informed consent
Exclusion
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy
- Active malignancy
- Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture
- 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
- Chronic use of medications that may compromise cognitive function and cannot be stopped: Anticonvulsants, Anticholinergics, antiparkinsonian, corticosteroids, Benzodiazepines
- Moderate to severe sleep apnea with no use of CPAP
- Diagnosis of a psychiatric disorder including: major depression, schizophrenia, bipolar disorder
- Serious suicidal ideation
- Renal or liver insufficiency, electrolyte imbalances
- Chronic heart failure with ejection fraction of 35 or less
- HBOT for any reason prior to study enrolment
- Chest pathology incompatible with pressure changes (including active asthma or COPD)
- Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
- An inability to perform an awake brain MRI or Amyloid PET
- An inability to perform computerized cognitive tests (Neurotrax)
- MMSE score below 20
- No evidence of amyloid in the brain PET
- No evidence of vascular related lesions in the brain MRI
- Active smoking
- Participation in another study
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05349318
Start Date
March 31 2022
End Date
March 1 2025
Last Update
February 6 2024
Active Locations (1)
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1
Shamir Medical Center (Assaf Harofeh)
Ẕerifin, Israel, 70300