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

R

Rennes University Hospital

Status and phase

Completed
Phase 3

Conditions

Parkinsons's Disease

Treatments

Drug: Usual dopaminergic per os treatment
Drug: Continuous Apomorphine infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT01039090
LOC/08-08
2008-006045-10

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

21 participants in 2 patient groups

Per os dopaminergic treatment
Active Comparator group
Treatment:
Drug: Usual dopaminergic per os treatment
Continuous Apomorphine infusion
Experimental group
Treatment:
Drug: Continuous Apomorphine infusion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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