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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00696215 |
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Date of registration:
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10/06/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease
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Scientific title:
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The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Over 3 Months |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00696215 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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MURAT EMRE, PROF |
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Address:
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Telephone:
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Email:
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Affiliation:
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ISTANBUL FACULTY OF MEDICINE |
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Name:
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MURAT EMRE, PROF. DR |
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Address:
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Telephone:
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90-21-2533-8575 |
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Email:
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muratemre@superonline.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: rasagiline
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Drug: placebo
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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