Impact of the Combined Treatment of Liposomed Polyphenols With G04CB02 on the ALS Patients

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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 G04CB02 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
• Treatments: Curcumin; Dutasteride; Resveratrol

Criteria

Inclusion Criteria:

• All ALS patients, over 18 years of age and with a clear diagnosis and symptomatology of ALS since at least 6 months.

Exclusion Criteria:

• Women under 50 years of age and childbearing age.

• Tracheotomy patients.

• Patients with invasive or non-invasive ventilation with positive ventilatory pressure

• Gastrectomized patients.

• Patients with evidence of dementia.

• Patients with alcohol or drug abuse dependency.

• Patients infected with B or C hepatitis, or HIV positive

• Renal patients with creatinine levels twice as high as normal markers.

• Liver patients with liver markers (ALT, AST) elevated 3 times above normal levels.

• Patients included in other research with drugs or therapies in the experimental phase.

• Patients treated with anticoagulants or with haemostatic problems