Impact of the Combined Treatment of Liposomed Polyphenols With G04CB02 on the ALS Patients
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Fundación Universidad Católica de Valencia San Vicente Mártir