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A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy

NCT ID: NCT01497652

Last Updated: 2015-12-16

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-03-31

Brief Summary

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The present pilot study is designed to assess the extent to which rasagiline may improve cognition in Parkinson's disease patients requiring dopaminergic therapy. The primary objective is to assess improvement in the Montreal Cognitive Assessment (MoCA) in patients who have been on rasagiline at 1mg daily for twelve weeks. The secondary objective is to assess changes in the SCOPA-COG, FAB, and UPDRS II \& III at the end of week 14.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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Parkinson's Disease Cognition Rasagiline MoCA Mild Cognitive Impairment in Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Group

Treatment group will receive Rasagiline (Azilect) 1mg daily

Group Type ACTIVE_COMPARATOR

Rasagiline

Intervention Type DRUG

0.5 mg for two weeks, then 1 mg for 12 weeks.

Placebo Group

will receive placebo daily

Group Type PLACEBO_COMPARATOR

Rasagiline/Placebo

Intervention Type DRUG

Will receive placebo pills each day for the entire 14 weeks.

Interventions

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Rasagiline/Placebo

Will receive placebo pills each day for the entire 14 weeks.

Intervention Type DRUG

Rasagiline

0.5 mg for two weeks, then 1 mg for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Sugar pill Azilect

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 40 or older with idiopathic Parkinson's disease on stable dopaminergic therapy for at least 1 month. The UK Brain Bank Criteria will be used to establish the diagnosis of Parkinson's disease. Women must be post menopausal or agree to avoid pregnancy. Modified Hoehn \& Yahr staging \< 3 and MoCA score must be greater than 21 but less than 28. Geriatric Depression Scale (GDS) is a sensitive and specific screen for depression in the Parkinson's disease population. GDS scores of \< 5 will be included in the study.

Exclusion Criteria

* Patients with secondary dementia, severe depression and atypical Parkinson's syndromes or Parkinson's plus will be excluded from the study. Patients on acetylcholine esterase or NMDA inhibitor medication will be excluded from the study. Patients with history of brain surgery for Parkinson's disease, stroke or significant head injury, active epilepsy will be excluded. Patients on Amantidine, neuroleptics, metoclopramide, alphamethyldopa within the last 6 months will be excluded. Individuals using meperidine, and tramadol will be excluded. Patients with congestive heart failure or myocardial infarction will also be excluded to avoid vascular dementia.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Neuroscience, Inc.

INDUSTRY

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando L Pagan, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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IIT-TN-067

Identifier Type: -

Identifier Source: org_study_id