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Motor Function Efficacy of Pharmacological Treatments Targeting Energy Metabolism, in Parkinson's Patients

NCT05855577 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease
  • Gait Analysis
  • Therapy, Directly Observed
  • Metabolic Disease

Interventions

DRUG

Terazosin

Treatment of Terazosine vs placebo and Lisosan-G vs placebo in cross-over double-blind, double-dummy

Sponsors & Collaborators

  • Università Foro Italico Roma

    collaborator OTHER

  • CNR Pisa

    collaborator UNKNOWN

  • I.R.C.C.S. Fondazione Santa Lucia

    lead OTHER

Principal Investigators

  • Antonella Peppe, MD, PhD · IRCCS Fondazione Santa Lucia Roma-Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2026-05-31
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05855577 on ClinicalTrials.gov