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

NCT ID: NCT00696215

Last Updated: 2008-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Keywords

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Parkinson's disease rasagiline cognition MAO-B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo 1 mg once a day

2

Rasagiline

Group Type ACTIVE_COMPARATOR

rasagiline

Intervention Type DRUG

1mg

Interventions

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placebo

Placebo 1 mg once a day

Intervention Type DRUG

rasagiline

1mg

Intervention Type DRUG

Other Intervention Names

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Azilect

Eligibility 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Istanbul Faculty of Medicine

Principal Investigators

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MURAT EMRE, PROF

Role: PRINCIPAL_INVESTIGATOR

ISTANBUL FACULTY OF MEDICINE

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Raif Cakmur

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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MURAT EMRE, PROF. DR

Role: CONTACT

Phone: 90-21-2533-8575

Email: [email protected]

HASMET A HANAGASI, DR

Role: CONTACT

Phone: 90-21-2533-8575

Email: [email protected]

Facility Contacts

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NESE TUNCER

Role: primary

RAIF CAKMUR, PROF.DR

Role: primary

Other Identifiers

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11719A

Identifier Type: -

Identifier Source: org_study_id