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

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ClinicalTrials.gov Identifier: NCT00696215
Recruitment Status : Unknown
Verified June 2008 by Istanbul University.
Recruitment status was:  Recruiting
First Posted : June 12, 2008
Last Update Posted : June 12, 2008
Sponsor:
Information provided by:
Istanbul University

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 Type : Interventional  (Clinical Trial)
Estimated 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 : June 2007
Estimated Primary Completion Date : June 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 1 Drug: placebo
Placebo 1 mg once a day

Active Comparator: 2
Rasagiline
Drug: rasagiline
1mg
Other Name: Azilect




Primary Outcome Measures :
  1. 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. [ Time Frame: 30 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 3 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696215


Contacts
Contact: MURAT EMRE, PROF. DR 90-21-2533-8575 muratemre@superonline.com
Contact: HASMET A HANAGASI, DR 90-21-2533-8575 hasmet@yahoo.com

Locations
Turkey
Marmara University Recruiting
Istanbul, Turkey
Contact: NESE TUNCER         
Raif Cakmur Recruiting
Izmir, Turkey
Contact: RAIF CAKMUR, PROF.DR         
Sponsors and Collaborators
Istanbul University
Investigators
Principal Investigator: MURAT EMRE, PROF ISTANBUL FACULTY OF MEDICINE

Responsible Party: Prof. Murat Emre, Istanbul Faculty of Medicine
ClinicalTrials.gov Identifier: NCT00696215     History of Changes
Other Study ID Numbers: 11719A
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: June 12, 2008
Last Verified: June 2008

Keywords provided by Istanbul University:
Parkinson's disease
rasagiline
cognition
MAO-B

Additional relevant MeSH terms:
Parkinson Disease
Cognition Disorders
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs