Motor Function Efficacy of Pharmacological Treatments Targeting Energy Metabolism, in Parkinson's… (NCT05855577) | Clinical Trial Compass
UnknownPhase 4
Motor Function Efficacy of Pharmacological Treatments Targeting Energy Metabolism, in Parkinson's Patients
50 participantsStarted 2023-12
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing pharmacological treatments that target energy metabolism in Parkinson's disease — can you explain what that means in practice, and whether there's a reason to think my Parkinson's might have a metabolic component that makes me a candidate worth discussing?
2Since this is a Phase 4 trial, the treatments being studied have already been approved — does that mean there's more established safety data compared to earlier-phase trials, and how does that change the risk-benefit conversation for someone in my situation?
3The trial measures outcomes using gait analysis alongside metabolic variables — what would my current walking difficulties and metabolic health look like compared to what they're trying to evaluate, and is that level of monitoring something that fits my situation?
4The recruitment status is listed as 'unknown' — do you know if this trial is still actively enrolling patients, or whether there are similar trials I should be looking into instead?
5Before considering a trial like this, should I first try or exhaust the standard pharmacological options for Parkinson's motor symptoms, or is there a reason this metabolic approach might be worth exploring sooner in my treatment journey?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical evaluation, Gait Analysis and Metabolic variables efficacy of therapy