UnknownNot Applicable

Common Noradrenergic Mechanisms in Parkinson´s Disease and L-DOPA Induced Dyskinesia

Denmark45 participantsStarted 2012-01

Plain-language summary

The aims of this proposal include tests of hypotheses of the pathogenetic mechanisms of noradrenergic neurotransmission in Parkinson's disease in vivo, using positron emission tomography of patients with early and advanced Parkinson's disease with or without 3,4 L-dihydroxyphenylalanine (L-DOPA) - induced dyskinesia or co-morbid depression, and evaluation of whether these mechanisms can be influenced therapeutically. Hypotheses: 1. The investigators argue that release in human cortical and subcortical brain regions of norepinephrine (NE) derived from metabolism of exogenousL-DOPA is greater in Parkinson's disease patients with L-DOPA- induced dyskinesia than in patients without this complication. This hypothesis will be tested by measuring antagonist \[11C\]yohimbine binding to alpha-2 adrenoceptors before and after L-DOPA challenge. 2. If so, it is argued that the greater rise of norepinephrine, measured as \[11C\]yohimbine displacement after L-DOPA challenge, is the result of down-regulation or loss of norepinephrine transporters. This hypothesis will be tested by measuring the binding of \[11C\]MeNER, a tracer of norepinephrine transporters. 3. If so, the investigators argue that the greater decline of \[11C\]MeNER binding is significantly correlated to the symptoms of Parkinson's disease, as proof that patients with more severe loss of noradrenergic terminals exhibit more severe motor deficits.

Who can participate

Age range

50 Years – 80 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: * 15 patients with PD in the age between 50 og 80, Hoehn og Yahr stage 2-3, never L-DOPA induced dyskinesia. * 15 patients with PD in the age between 50 og 80 år, Hoehn og Yahr stage 2-3, with established L-DOPA induced dyskinesia. * 15 age matched healthy controls. Exclusion Criteria: * Psychiatric or neurological disease, not related to Parkinson´s disease. * Cancer and malignant disease. * Liver or kidney disease. * Alcohol or substance abuse. * Cardiac disease. * Treatment with antipsychotics or antiepileptics or other medications that affect the noradrenergic system. Medicines to treat Parkinson´s disease are allowed. * Patients treated with deep brain stimulation.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Noradrenaline release

Timeframe: Up to 16 months

Trial details

NCT IDNCT02578849

SponsorAarhus University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-01

Contact for this trial

Adjmal Nahimi, MD

+4553639856 adjmalnahimi@gmail.com

View on ClinicalTrials.gov More Parkinson´s Disease trials