Mild Cognitive Impairment and Vascular Subcortical Ischemia Clinical Trial
Official title:
Hyperbaric Oxygen Therapy in Patients Suffering From Mild Cognitive Impairment and Vascular Subcortical Ischemia
Dementia is a very frequent cognitive disorder among elderly individuals. Its prevalence is
about 15-20% of the population over the age of 65. The most common forms of dementia among
the elderly demented patients are Alzheimer's disease (AD) (prevalence of 70%) and Vascular
dementia (VD) (prevalence of about 30-40%).There is also a high rate (about 40%) of
coexisting of AD and VD among the dementia patients, defined as mixed dementia.
Mild Cognitive Impairment (MCI) is a pre-dementia phase of cognitive decline. It is also
considered as a prodromal phase of both VD and AD. Its basic clinical features include:
cognitive concern, reflecting a change in cognition, reported by the patient or informant
(i.e., historical or observed evidence of decline over time), with objective evidence of
impairment in one or more cognitive domains (i.e., by formal cognitive testing), as well as
preservation of independence in functional abilities and not being demented (i.e., no
significant impairment social or occupational functioning).
Hyperbaric oxygen therapy (HBOT) has been investigated for treatment of numerous diseases
for more than 300 years. The principal effect of HBOT is increasing the solubility of oxygen
in plasma to a level sufficient to support tissues with minimal oxygen supply carried on by
hemoglobin. Clinical studies published this year present convincing evidence that hyperbaric
oxygen therapy (HBOT) can be the coveted neurotherapeutic method for brain repair. Thus, it
seems that HBOT might be an efficient and clinically feasible method capable of increasing
tissue/cellular oxygenation and effectively evoking neuroplasticity in the chronically
vascular-lesioned areas during the post microvascular lesion phase.
This is a prospective, randomized, control crossed over, study evaluating the effect of HBOT
in patients suffering from Mild Cognitive Impairment and Vascular Subcortical Ischemia.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment