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Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's Disease (APO-TEP)

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ClinicalTrials.gov Identifier: NCT01039090
Recruitment Status : Unknown
Verified November 2012 by Rennes University Hospital.
Recruitment status was:  Recruiting
First Posted : December 24, 2009
Last Update Posted : December 3, 2012
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment Phase
Parkinsons's Disease Drug: Continuous Apomorphine infusion Drug: Usual dopaminergic per os treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2009
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : August 2014

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Arm Intervention/treatment
Active Comparator: Per os dopaminergic treatment Drug: Usual dopaminergic per os treatment
No specific change in the dopaminergic per os treatment

Experimental: Continuous Apomorphine infusion Drug: Continuous Apomorphine infusion
Continuous Apomorphine infusion during 6 months




Primary Outcome Measures :
  1. Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039090


Contacts
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Contact: Dorothée VIDET-GIBOU, MD dgibou@yahoo.fr

Locations
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France
Rennes University Hospital Recruiting
Rennes, France, 35000
Contact: Dorothée VIDET-GIBOU, MD       dgibou@yahoo.fr   
Principal Investigator: Marc VERIN, MD PhD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Marc VERIN, MD PhD Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01039090     History of Changes
Other Study ID Numbers: 2008-006045-10
LOC/08-08
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012

Keywords provided by Rennes University Hospital:
Not eligible for deep brain stimulation
Parkinsons's patients

Additional relevant MeSH terms:
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Apomorphine
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine Agonists
Dopamine
Emetics
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Sympathomimetics
Protective Agents