Status:
UNKNOWN
The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease
Lead Sponsor:
Istanbul University
Conditions:
Parkinson's Disease
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The objective of the study is to assess the effects of rasagiline on cognitive functions in patient with Parkinson's disease. Patients on any dopaminergic medications will be assigned to receive rasag...
Detailed Description
The primary objective of this study is to assess the effects of rasagiline on cognitive deficits in non-demented patients with PD. The secondary objective is to assess affective changes in this patien...
Eligibility Criteria
Inclusion
- Male and female patients of any age
- Diagnosis of Idiopathic PD according to the UK Brain Bank Criteria for the clinical diagnosis of PD.
- Patients with cognitive impairment associated with PD, defined as:
- Subjective complaints of impaired cognitive functions such as forgetfulness, word finding difficulties or inattentiveness
- Presence of objectively demonstrable cognitive deficits in at least 2 out of the 4 cognitive domains typically impaired in PD. These include attention, executive functions, memory and visuo-spatial functions. The performance in the following test scores must be 1.5 standard deviations below the mean normative score for age and education of the patient: Digit Span for attention, Letter Fluency test for executive function, Logical Memory Sub-scale from the Wechsler Memory Scale-Revised and Line Orientation Test for visuo-spatial function.
- Patients with a Hoehn and Yahr stage I-III when "on"
- Literate patients who are able to follow test instructions
Exclusion
- Diagnosis of dementia due to PD according to DSM IV criteria
- Diagnosis of current major depressive episode according to DSM IV criteria
- Presence of any other neurodegenerative disorder other than PD
- Presence of any unstable or untreated systemic disorder such as diabetes, cardiac failure, renal failure
- Use of any prohibited concomitant medication
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00696215
Start Date
June 1 2007
End Date
October 1 2008
Last Update
June 12 2008
Active Locations (2)
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1
Marmara University
Istanbul, Turkey (Türkiye)
2
Raif Cakmur
Izmir, Turkey (Türkiye)