Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's Disease
Information source: Rennes University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinsons's Disease
Intervention: Continuous Apomorphine infusion (Drug); Usual dopaminergic per os treatment (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Rennes University Hospital Official(s) and/or principal investigator(s): Marc VERIN, MD PhD, Principal Investigator, Affiliation: Rennes University Hospital
Overall contact: Dorothée VIDET-GIBOU, MD, Email: dgibou@yahoo.fr
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Dorothée VIDET-GIBOU, MD, Email: dgibou@yahoo.fr
Rennes University Hospital, Rennes 35000, France; Recruiting Dorothée VIDET-GIBOU, MD, Email: dgibou@yahoo.fr Marc VERIN, MD PhD, Principal Investigator
Additional Information
Starting date: February 2009
Last updated: November 30, 2012
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