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

Sponsor

Istanbul University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00696215

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: placebo Drug: rasagiline	Phase 4

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 patient population. This will be a randomized, double-blind, placebo controlled study in 1-3 centers. Patients will be recruited from the Movement Disorders Outpatients Clinic, Department of Neurology, Istanbul Faculty of Medicine, Dokuz Eylul University and Marmara University. Eligible patients will be randomly assigned to rasagiline 1 mg or placebo. Patients will be treated with the study medication over 3 months. Cognitive and behavioral assessments will be performed at baseline, at 4 weeks and at the end of the study, at 12 weeks. A total of 40 PD patients with cognitive deficits, but without dementia will be recruited. No sample size calculation will be performed, a sample of convenience will be used.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Over 3 Months

Study Start Date :

Jun 1, 2007

Anticipated Primary Completion Date :

Jun 1, 2008

Anticipated Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1	Drug: placebo Placebo 1 mg once a day
Active Comparator: 2 Rasagiline	Drug: rasagiline 1mg Other Names: Azilect

Arm

Intervention/Treatment

Placebo Comparator: 1

Drug: placebo

Placebo 1 mg once a day

Active Comparator: 2

Rasagiline

Drug: rasagiline

1mg

Other Names:

Azilect

Outcome Measures

Primary Outcome Measures

The primary outcome measure will be the total cognitive score. This will be calculated by adding the four cognitive sub-scores: attention, executive function, memory and visuo-spatial function. [30 months]

Secondary Outcome Measures

The four cognitive sub-scores as well as individual tests scores will be analyzed separately. The changes from baseline to the end of the study in the GDS, STAS and UPDRS part III scales will be analyzed. [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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