The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease
- Conditions
- Parkinson's disease034034
- Registration Number
- JPRN-jRCTs051180098
- Lead Sponsor
- Ito Hidefumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 120
(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 28 days 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 25 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.
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percent change of SBR of DAT-SPECT from the first evaluation to the final evaluation at 1 year
- Secondary Outcome Measures
Name Time Method - Change in UPDRS score (PartII, PartIII)<br>- Change in PDQ-39 score