Parkinson'
Conditions
Interventions
L-Dopa/DCI only The drug is administered per oral at 150 to 300 mg/day. The treatment is started within 14days after registration and continued until day 365.
L-Dopa/DCI + selegiline L-Dopa/DCI i
Sponsors
Osaka Redcross Hospital Wakayama Prefectural Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1). Those who are at age between 55 and 79 years. 2).The patients should be within 3 years after the onset of motor symptoms 3). The patients should be treated with levodopa/DCI within 3 months and with levodopa/DCI exclusively one month right before starting the trial. 4) The dose of levodopa/DCI should be taken from 150mg/day to 300mg/day. 5)The participant's score of MMSE should be 24 or higher. 6) The patient should be judged by attendant doctor to be appropriate for registration. 7) The agreement with the study should be obtained by the document,
Exclusion criteria
Exclusion criteria: Those who matched the following conditions should be excluded. 1). Those who had been treated with the anti-parkinsonian drugs except levodopa/DCI for more than 1month. 2).Those who are in pregnancy, or possible to be pregnant or those who are in the breast-feeding. 3) Those who have taken antidepressant and/or anti-psychotic drugs. 4) Those who have a history of stroke and cerebrovascular disorders. 5) Those who had a history of epilepsy or those who are in treatment of epilepsy 6) Those who have a history of alcohol intoxication, or have the treatment for alcoholic abuse 7) Those who have severe comorbidity( liver dysfunction, renal dysfunction and endocrinological disorders). 8) Those who have a familial history of Parkinson's disease 9) Those who have a history of allergic reaction with 123I- ioflupane.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The neuroprotective effect is evaluated by 123I-FP-CIT SPECT after 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical symptoms are evaluated by UPDRS partII, UPDRS partIII, PDQ-39 | — |
Countries
Japan
Contacts
Public ContactHidefumi Ito
Wakayama Prefectural Medical College Neurology
Outcome results
None listed