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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 (RECOGNIZE)

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Rasagiline/Placebo

Rasagiline

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Cognition, Rasagiline, MoCA, Mild Cognitive Impairment in Parkinson's Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Georgetown University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment Group

Placebo Group

Arm Description

Treatment group will receive Rasagiline (Azilect) 1mg daily

will receive placebo daily

Outcomes

Primary Outcome Measures

Montreal Cognitive Assessment

Best value is 30 and Worst Value is 0. Scores for a series of subscales are not combined for a total overall score.

Secondary Outcome Measures

Full Information

NCT ID

NCT01497652

First Posted

December 20, 2011

Last Updated

December 15, 2015

Sponsor

Georgetown University

Collaborators

Teva Neuroscience, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01497652

Brief Title

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

Acronym

RECOGNIZE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Georgetown University

Collaborators

Teva Neuroscience, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Active Comparator

Arm Description

Treatment group will receive Rasagiline (Azilect) 1mg daily

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

will receive placebo daily

Intervention Type

Drug

Intervention Name(s)

Rasagiline/Placebo

Other Intervention Name(s)

Sugar pill

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rasagiline

Other Intervention Name(s)

Azilect

Intervention Description

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

Primary Outcome Measure Information:

Title

Montreal Cognitive Assessment

Description

Best value is 30 and Worst Value is 0. Scores for a series of subscales are not combined for a total overall score.

Time Frame

14 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando L Pagan, MD

Organizational Affiliation

Georgetown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgetown University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

12. IPD Sharing Statement

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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

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