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

NCT05855577 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: RF-2021-12374979
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

parkinson's disease; gait Analysis; mitocondrial; therapy

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation, Gait Analysis and Metabolic variables efficacy of therapy

  MD UPDRs : Four Parts: II questionary by Parkinsonian or care-given, III-IV: Motor Part and Complication by neurologist , Each item rate from 0: no sign to 4: max sign PDQ39 questionary performed by Parkinsonian each item rate from 0: never, to 5:always. Gait Analysis following spatio-temporal parameters will be taken in to account: Right and Left Step Length, Stride time% Stance Swing , Double support t, Mean Velocity, Cadence, Stepwidth, and t for turning task:• Number of steps to complete the lap,• Lap time, Metabolomic Variables: Steady State oxygen uptake (VO2, mlkg-1min-1) and carbon dioxide production (VCO2), heart rate (HR), Walking energy cost per unit of time-WECt8Jkg-1min-1),Metabolic human blood variabes : G6PD mU/109 erytrocytes, CAT, GPx, NQO1,HO-1,SOD: U/mg protein, GSH mmol GSH/l, MDA mmol/MDA/l,NrF2 gene expression

  2year

Secondary Outcomes (1)

• The efficacy and molecular mechanisms of Nrf2 pathway modulation in PD rodent models

  2 years

Study Arms (4)

Terazosine

EXPERIMENTAL

Pharmacological Treatment of Pakinson's disease patients using Terazosin 2 mg

Drug: Terazosin

placebo T

PLACEBO COMPARATOR

Pharmacological Treatment of Parkinson's disease patients using Placebo

Drug: Terazosin

Lisosan-G (Nutritional Supplement)

EXPERIMENTAL

Treatment of Parkinson's disease patients using Lisosan-G

Drug: Terazosin

Lisosan_G Placebo

PLACEBO COMPARATOR

Treatment of Parkinson's disease patients using Lisosan-G

Drug: Terazosin

Interventions

Terazosin DRUG

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

Also known as: Lisosan-g

Lisosan-G (Nutritional Supplement); Lisosan_G Placebo; Terazosine; placebo T

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead
• Università Foro Italico Roma: collaborator
• CNR Pisa: collaborator

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MeSH Terms

Conditions

Parkinson Disease; Directly Observed Therapy; Metabolic Diseases

Interventions

Terazosin; Lisosan G

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Nutritional and Metabolic Diseases

Study Officials

• Antonella Peppe, MD, PhD

  IRCCS Fondazione Santa Lucia Roma-Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella Peppe, MD

CONTACT

+39 3493746450; a.peppe@hsantalucia.it

Giusy Martella, DR

CONTACT

+39 3293112506; martellag@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigators that visit the patient and perform Gait Analysis are Blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: May 11, 2023
• Study Start: December 1, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share