Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's Disease

Study Overview
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Brief Summary
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In Parkinson's disease, treatment mainly aims to improve motor functions. However, other dysfunctions are often observed in Parkinson's patients, and may have important consequences on the quality of life of patients. Cognitive and neuropsychological troubles may be observed, as memory impairment or anxiety for example. As this kind of troubles is worrying for the patient himself (herself) and his/her family, treatment needs to take into account those troubles in addition to motor difficulties. In our centre, we have already used continuous Apomorphine infusions among Parkinson's patients and it seems to have good results. The present study aims to objectively assess the efficacy of continuous Apomorphine infusions on cognitive and neuropsychological functions in Parkinson's disease using clinical and positron emission tomography (PET)-scan measures.

Official Title
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Prospective, Randomised, Comparative Study Comparing Efficacy of Continuous Apomorphine Infusion Versus Usual Dopaminergic Per os Treatment on Cognitive and Neuropsychological Functions in Parkinson's Disease: a Clinical and PET-scan Study

Conditions
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Parkinsons's Disease

Intervention / Treatment
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* Drug: Continuous Apomorphine infusion
* Drug: Usual dopaminergic per os treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and more Parkinson's disease according to UKPDSBB diagnosis criteria Motor difficulties in spite of dopaminergic per os treatment Not eligible for deep brain stimulation for one or more reasons (age>70, axial troubles in spite of dopaminergic per os treatment, cognitive troubles and/or hallucinations) Exclusion Criteria: Mattis scale < 120 Contraindication to Apomorphine (liver insufficiency, severe cognitive troubles, allergy, pregnancy, neuroleptic treatment) Contraindication to Fluoro-Deoxy-Glucose which is used in PET-Scan (allergy, kidney failure, pregnancy, breast feeding)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Per os dopaminergic treatment<br> | Drug: Usual dopaminergic per os treatment<br>* No specific change in the dopaminergic per os treatment<br>|
| Experimental: Continuous Apomorphine infusion<br> | Drug: Continuous Apomorphine infusion<br>* Continuous Apomorphine infusion during 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Not eligible for deep brain stimulation, Parkinsons's patients