Amyotrophic lateral sclerosis (ALS) is a disease of an inflammatory nature, which causes progressive muscle weakness associated with cognitive and behavioural disorders. Pathogenically, it is characterised by loss of oxidative control, excitotoxicity due to excess glutamate and intestinal dysbiosis. In the absence of curative treatment, the aim of the study is to assess the impact at a clinical level of the combination of liposomed polyphenols to improve their effectiveness, with the drug Dutasteride which shows great anti-ALS properties by Molecular Topology methodology. A prospective, longitudinal, mixed, analytical, experimental and double-blind study is proposed, with a population sample of 100 patients distributed randomly in 50 patients in the intervention group who will receive treatment for 6 months, and 50 patients in the control group who will receive a placebo for the same period. The assessment will be at time 0, and at 3 months and 6 months after treatment, with functional, cognitive and behavioural tests, and of the state of inflammation and oxidation; and at time 0 and 6 months, of the intestinal microbiota.
Name: Liposomed polyphenols resveratrol and curcumin
Name: Placebo for liposomed resveratrol and curcumin
Name: Isocaloric Diet
Name: Dutasteride 0.5 mg
Name: Placebo microcrystalline methylcellulose
Description: Maximum value: 48 points; Means better outcome motor variables Minimum value: 0 points
Measure: Revised Amyotrophic Lateral Sclerosis Functional Rating Scale associated with ALS Time: Time 0Description: Maximum value: 48 points; Means better outcome motor variables Minimum value: 0 points
Measure: Revised Amyotrophic Lateral Sclerosis Functional Rating Scale associated with ALS Time: 3 monthsDescription: Maximum value: 48 points; Means better outcome motor variables Minimum value: 0 points
Measure: Revised Amyotrophic Lateral Sclerosis Functional Rating Scale associated with ALS Time: 6 monthsDescription: Motor Variables
Measure: Electromyography Time: Time 0Description: Motor Variables
Measure: Electromyography Time: 3 monthsDescription: Motor Variables
Measure: Electromyography Time: 6 monthsDescription: Motor Variables
Measure: Measurement of forced vital capacity Time: Time 0Description: Motor Variables
Measure: Measurement of forced vital capacity Time: 3 monthsDescription: Motor Variables
Measure: Measurement of forced vital capacity Time: 6 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma IL-6 and TNF-alpha. Time: Time 0Description: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma IL-6 and TNF-alpha. Time: 3 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma IL-6 and TNF-alpha. Time: 6 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma PCR. Time: Time 0Description: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma PCR. Time: 3 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma PCR. Time: 6 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma haptoglobin. Time: Time 0Description: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma haptoglobin. Time: 3 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma haptoglobin. Time: 6 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of TEAC (oxidation). Time: Time 0Description: Variables related to inflammation and oxidation
Measure: Quantitative measurement of TEAC (oxidation). Time: 3 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of TEAC (oxidation). Time: 6 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma 8-oxoG. Time: Time 0Description: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma 8-oxoG. Time: 3 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma 8-oxoG. Time: 6 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma MDA. Time: Time 0Description: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma MDA. Time: 3 monthsDescription: Variables related to inflammation and oxidation
Measure: Quantitative measurement of plasma MDA. Time: 6 monthsDescription: Variable for cognitive and behavioural assesment Maximum value: 136 points; Means better outcome Minimum value: 0 points Includes a behavioural test to interview the care provider
Measure: Edinburgh Cognitive and Behavioral ALS Screen Time: Time 0Description: Variable for cognitive and behavioural assesment Maximum value: 136 points; Means better outcome Minimum value: 0 points Includes a behavioural test to interview the care provider
Measure: Edinburgh Cognitive and Behavioral ALS Screen Time: 3 monthsDescription: Variable for cognitive and behavioural assesment Maximum value: 136 points; Means better outcome Minimum value: 0 points Includes a behavioural test to interview the care provider
Measure: Edinburgh Cognitive and Behavioral ALS Screen Time: 6 monthsDescription: Variable for cognitive and behavioural assesment Maximum value: 18 points; Means better outcome 16-15 points means frontosubcortical deficit 13-12 points means frontosubcortical dementia Minimum value: 0 points Includes a behavioural test to interview the care provider
Measure: Frontal Assessment Battery Time: Time 0Description: Variable for cognitive and behavioural assesment Maximum value: 18 points; Means better outcome 16-15 points means frontosubcortical deficit 13-12 points means frontosubcortical dementia Minimum value: 0 points Includes a behavioural test to interview the care provider
Measure: Frontal Assessment Battery Time: 3 monthsDescription: Variable for cognitive and behavioural assesment Maximum value: 18 points; Means better outcome 16-15 points means frontosubcortical deficit 13-12 points means frontosubcortical dementia Minimum value: 0 points Includes a behavioural test to interview the care provider
Measure: Frontal Assessment Battery Time: 6 monthsDescription: A Clinical Intestinal Microbiome will be performed, which is an analysis of the bacterial microbiota present in the intestine, from a stool sample.
Measure: Variables related to the microbiota Time: Time 0Description: A Clinical Intestinal Microbiome will be performed, which is an analysis of the bacterial microbiota present in the intestine, from a stool sample.
Measure: Variables related to the microbiota Time: 6 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
Both mediators promoted the normalization of autophage flow and, more importantly, increased mitochondrial biogenesis in SOD1-G93A mice. --- G93A ---