Parkinson's Disease
Conditions
Interventions
Trade Name: Ebixa
Product Name: Ebixa
Pharmaceutical Form: Tablet
INN or Proposed INN: memantine
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 10 mg-
Sponsors
Neurologisk afdeling F
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1) Idiopathic Parkinson's Disease (ICD-10: G20.9) 2) Age 50-70 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients: 1) Any current use of tobacco substances containing nicotine. 2) Conditions prohibiting MR scan (implanted pacemaker, protheses etc.) 3) Brain diseases apart from Parkinson's Disease (Aneurisms, AV-malformations, stroke, cranial trauma, dementia etc.) 4) Psychiatric disorders (Schizophrenia, bi-polar mood disorder, depression) 5) Other major diseases (heartfailure, arhytmias, infarcts, kidney failure, liver failure, cirrhosis, active hepatitis, portal hypertension etc.) 6) Current use of drugs with major influence on CNS (eg. amphetamine, metamphetamine, cocaine, opioids, antipsychotics, antiepileptics, NMDA-antagonists) 7) Current use of the anti-parkinsonian drugs Cabergolin and Amantadine. 8) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Using PET tracers (15O Oxygen, 15O H2O, F-DOPA) we wish to evaluate the changes in: 1) Regional oxidative metabolism (rCMRO2) in cortex and basal ganglia before and after trial of Memantine. 2) Regional cerebral blood flow (rCBF) before and after trial of Memantine. 3) Dopamine metabolism before and after trial of Memantine.;Main Objective: To elucidate Memantines actions in brain of patients with Parkinson's disease. Administer MEMANTINE for 6 weeks (3 weeks uptitration to final dose of 2x10 mg daily to be administered in week 4, 5 and 6) to patients with Parkinson's Disease. Using PET methodology we wish to evaluate changes in: 1) Regional cerebral cortical oxidative metabolism (rCMRO2) before and after trial of Memantine. 2) Regional basal ganglia oxidative metabolism (rCMRO2) before and after trial of Memantine. 3) Regional cerebral blood flow (rCBF) before and after trial of Memantine. 4) Dopamine metabolism before and after trial of Memantine.;Secondary Objective: UPDRS score improvements in patients with Parkinson's Disease after 6 weeks treatment with memantine. | — |
Countries
Denmark
Outcome results
None listed