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
Overview
- Phase
- Phase 3
- Intervention
- Continuous Apomorphine infusion
- Conditions
- Parkinsons's Disease
- Sponsor
- Rennes University Hospital
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Continuous Apomorphine infusion
Intervention: Continuous Apomorphine infusion
Per os dopaminergic treatment
Intervention: Usual dopaminergic per os treatment
Outcomes
Primary Outcomes
Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger
Time Frame: 6 months