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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-02-28

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.

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Detailed Description

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Conditions

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Parkinsons's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Per os dopaminergic treatment

Group Type ACTIVE_COMPARATOR

Usual dopaminergic per os treatment

Intervention Type DRUG

No specific change in the dopaminergic per os treatment

Continuous Apomorphine infusion

Group Type EXPERIMENTAL

Continuous Apomorphine infusion

Intervention Type DRUG

Continuous Apomorphine infusion during 6 months

Interventions

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Continuous Apomorphine infusion

Continuous Apomorphine infusion during 6 months

Intervention Type DRUG

Usual dopaminergic per os treatment

No specific change in the dopaminergic per os treatment

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No