Back to resultsEfficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's Disease (APO-TEP)
Primary Purpose
Parkinsons's Disease
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Continuous Apomorphine infusion
Usual dopaminergic per os treatment
Sponsored by
About this trial
This is an interventional treatment trial for Parkinsons's Disease focused on measuring Not eligible for deep brain stimulation, Parkinsons's patients
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)
Sites / Locations
- Rennes University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Per os dopaminergic treatment
Continuous Apomorphine infusion
Arm Description
Outcomes
Primary Outcome Measures
Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger
Secondary Outcome Measures
Full Information
NCT ID
NCT01039090
First Posted
December 22, 2009
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01039090
Brief Title
Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's Disease
Acronym
APO-TEP
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 Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 2009 (Actual)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsons's Disease
Keywords
Not eligible for deep brain stimulation, Parkinsons's patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Per os dopaminergic treatment
Arm Type
Active Comparator
Arm Title
Continuous Apomorphine infusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Continuous Apomorphine infusion
Intervention Description
Continuous Apomorphine infusion during 6 months
Intervention Type
Drug
Intervention Name(s)
Usual dopaminergic per os treatment
Intervention Description
No specific change in the dopaminergic per os treatment
Primary Outcome Measure Information:
Title
Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc VERIN, MD PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28017228
Citation
Auffret M, Le Jeune F, Maurus A, Drapier S, Houvenaghel JF, Robert GH, Sauleau P, Verin M. Apomorphine pump in advanced Parkinson's disease: Effects on motor and nonmotor symptoms with brain metabolism correlations. J Neurol Sci. 2017 Jan 15;372:279-287. doi: 10.1016/j.jns.2016.11.080. Epub 2016 Dec 2.
Results Reference
result
Learn more about this trial
Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's Disease
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