-Clinical Efficacy of Pharmacological Treatments Targeting Energy Metabolism, Evaluated by Gait Analysis, on Motor Function in Parkinson's Disease Patients

RF-2021-12374979

Consistent evidence suggests that mitochondrial dysfunction plays a crucial role in Parkinson¿s disease pathogenesis. Inhibition of complex I of the mitochondrial electron transport chain is sufficient to reproduce biochemical and pathological features of Parkinson¿s Disease in animal models (PD). Alterations of mitochondrial energy metabolism may intervene in PD pathogenesis by inducing inflammation, generation of reactive oxygen species (ROS), and neurodegeneration. The Nuclear factor erythroid 2-related factor 2 (Nrf2) is a regulator both of mitochondrial function and biogenesis, and of cellular resistance to oxidative stress, and may represent a novel target of PD disease-modifying therapies. The aims of the present study are to validate indicators of energy metabolism as biomarkers in PD patients and to evaluate the efficacy of drugs and natural food supplements acting on the Nrf2 pathway in improving motor impairment and Gait in PD patients.

2023-12-01

2026-05-01

2026-05-01

Not yet recruiting

Early phase I

50

Inclusion Criteria: * Patient with rigid-acinetic bilateral PD form * At least 5 years of disease history * H\&Y between 2-3.5 * Stable drug therapy response without any change performed in the 3 months before the study. * MMSE\>24/30 (Mini-Mental State Examination) * No severe gastrointestinal pathologies. Exclusion Criteria: * Systemic illness * Presence of cardiac pacemaker * Presence of deep brain stimulation * Presence of severe dysautonomia with marked hypotension * Obsessive-Compulsive Disorder (OCD) * Major depression * Dementia * History or active neoplasia * Pregnancy * Lack of autonomy in walking; * Malabsorption and gastrointestinal disorders; * Gluten intolerance * Ipotiroidism

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '25 M-PD (H\\&Y\\< 2.5) and 25 S-PD (H\\&Y \\> 2.5) patients with idiopathic PD will be enrolled sequentially in the randomized double-blind, double-dummy study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The investigators that visit the patient and perform Gait Analysis are Blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-09-22