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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

Page last updated: August 20, 2015

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