Alzheimer Disease Clinical Trial
Official title:
Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of a Vegetal Oil in the Disease's Natural Evolution in Patients Diagnosed With Cognitive Impairment or Mild to Moderate Alzheimer Disease.
The aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with a composition related to short, medium and long unsaturated chain fatty acids on patients with a diagnose of cognitive impairment or mild to moderate Alzheimer disease
The cognitive impairment syndrome is defined as a decrease of the intellectual performance
with respect to a previous step in time. The Cognitive impairment has to be considered as a
functional alteration with a continuous and physiological evolution in which happen a set of
different circumstances:
- A increasing and normal reduction, that appears after the age of sixty, also known as
Age-associated memory impairment (AAMI)
- A mild cognitive impairment (MCI), with a recent and mild loss of memory, but higher to
that expected because of patient's age and educational level.
- A severe pathological decrease of the mental abilities, also known as, depending on its
characteristics: Severe cognitive impairment (SCI), senile dementia and Alzheimer's
disease (1).
In the next years it is expected that this disease will become one of the main health and
aged-related problem in aged people.(2) Nowadays, there are 35,6 million people with any
kind of dementia, and it is estimated that every year, 7,7 million of new patients are
diagnosed. (3) The amount of people affected will probably duplicate every 20 years, if
effective treatments to stop its evolution are not developed. The forecast estimate up to
81,1 million of patients in 2040, which make this disease in a XXI century real epidemic.(4)
Before reaching the level of dementia, SCI or Alzheimer's disease, the patient will suffer a
progressive mild cognitive impairment. In this level, the disease can be early diagnosed and
it would be worth to act on it.
Evidences of the Polyunsaturated oils use on the prevention and/or treatment of cognitive
impairment.
Polyunsaturated fatty acids (PUFA) can help to improve the cognitive functions. Neuronal
tissues, as the brain, retina and the neurone-covering membranes (myelin) include high
levels of PUFA. (5) PUFA's act on the order transmission in the Nervous System. Population
studies reported the beneficial effect of fish oil, with a high PUFA concentration, on the
memory of patients suffering a mild cognitive impairment. (6) It can be also beneficial for
Alzheimer's patients, as they are deficient in PUFA's. A diet rich in PUFA'S can improve the
cognitive function on patients con cognitive impairment and Alzheimer's disease. (6-8)
Epidemiological studies suggest that oils rich in short chain PUFA, should play a beneficial
role stopping the initial progression of Alzheimer's disease.
The previous data confirm the possibility of a beneficial effect of the product to study (a
mixture of vegetable oils, rich in triglyceride and lecithins) due to the common
characteristic of the product with those PUFA's already marketed.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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