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

Primary Purpose

Parkinson's Disease

Status

Unknown status

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

placebo

rasagiline

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, rasagiline, cognition, MAO-B

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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:
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.
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

Sites / Locations

Marmara UniversityRecruiting
Raif CakmurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Rasagiline

Outcomes

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.

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.

Full Information

NCT ID

NCT00696215

First Posted

June 10, 2008

Last Updated

June 11, 2008

Sponsor

Istanbul University

1. Study Identification

Unique Protocol Identification Number

NCT00696215

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2007 (undefined)

Primary Completion Date

June 2008 (Anticipated)

Study Completion Date

October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Istanbul University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Parkinson's disease, rasagiline, cognition, MAO-B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Arm Description

Rasagiline

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo 1 mg once a day

Intervention Type

Drug

Intervention Name(s)

rasagiline

Other Intervention Name(s)

Azilect

Intervention Description

1mg

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

3 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

MURAT EMRE, PROF. DR

Phone

90-21-2533-8575

muratemre@superonline.com

First Name & Middle Initial & Last Name or Official Title & Degree

HASMET A HANAGASI, DR

Phone

90-21-2533-8575

hasmet@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MURAT EMRE, PROF

Organizational Affiliation

ISTANBUL FACULTY OF MEDICINE

Official's Role

Principal Investigator

Facility Information:

Facility Name

Marmara University

City

Istanbul

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

NESE TUNCER

Facility Name

Raif Cakmur

City

Izmir

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

RAIF CAKMUR, PROF.DR

12. IPD Sharing Statement

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

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