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

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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: placebo; Drug: rasagiline

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Marmara University
    • Contact: NESE TUNCER
  • Izmir, Turkey
    • Recruiting
    • Raif Cakmur
    • Contact: RAIF CAKMUR, PROF.DR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 1	Drug: placebo; Placebo 1 mg once a day
ACTIVE_COMPARATOR: 2; Rasagiline	Drug: rasagiline; 1mg; Other Names: Azilect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: MURAT EMRE, PROF, Istanbul Faculty of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ANTICIPATED): June 1, 2008
• Study Completion (ANTICIPATED): October 1, 2008

Study Registration Dates

• First Submitted: June 10, 2008
• First Submitted That Met QC Criteria: June 11, 2008
• First Posted (ESTIMATE): June 12, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 12, 2008
• Last Update Submitted That Met QC Criteria: June 11, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: cognition; Parkinson's disease; MAO-B; rasagiline
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Cognitive Dysfunction; Cognition Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Monoamine Oxidase Inhibitors; Rasagiline
• Other Study ID Numbers: 11719A