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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Istanbul University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00696215
First received: June 10, 2008
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Parkinson's Disease
Drug: placebo
Drug: rasagiline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Istanbul University:

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. [ Time Frame: 30 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
Placebo 1 mg once a day
Other Name: Placebo
Active Comparator: 2
Rasagiline
Drug: rasagiline
1mg
Other Name: Azilect

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Prof. Murat Emre, Istanbul Faculty of Medicine
ClinicalTrials.gov Identifier: NCT00696215     History of Changes
Other Study ID Numbers: 11719A
Study First Received: June 10, 2008
Last Updated: June 11, 2008
Health Authority: Turkey: Ministry of Health

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014