Overview

The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease

Status:
Unknown status

Trial end date:
2008-10-01

Target enrollment:
0

Participant gender:
All

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 rasagiline 1 mg or placebo over 3 months. Cognitive functions will be assessed by selected neuropsychological tests representing each cognitive domain.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Istanbul University

Treatments:

Rasagiline

Criteria

Inclusion Criteria:

1. Male and female patients of any age

2. Diagnosis of Idiopathic PD according to the UK Brain Bank Criteria for the clinical
diagnosis of PD.

3. Patients with cognitive impairment associated with PD, defined as:

1. Subjective complaints of impaired cognitive functions such as forgetfulness, word
finding difficulties or inattentiveness

2. 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.

4. Patients with a Hoehn and Yahr stage I-III when "on"

5. Literate patients who are able to follow test instructions

Exclusion Criteria:

1. Diagnosis of dementia due to PD according to DSM IV criteria

2. Diagnosis of current major depressive episode according to DSM IV criteria

3. Presence of any other neurodegenerative disorder other than PD

4. Presence of any unstable or untreated systemic disorder such as diabetes, cardiac
failure, renal failure

5. Use of any prohibited concomitant medication