A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients Receiving Dopaminergic Therapy (GUHIITCog2012)

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Teva Neuroscience, Inc.

Information provided by (Responsible Party):

Georgetown University

ClinicalTrials.gov Identifier:

NCT01497652

First received: December 20, 2011

Last updated: January 6, 2012

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2011

Last Updated Date

January 6, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Montreal Cognitive Assessment [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Montreal Cognitive Assessment [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01497652 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Drug: Rasagiline/Placebo
Will receive placebo pills each day for the entire 14 weeks.

Other Name: Sugar pill
Drug: Rasagiline
0.5 mg for two weeks, then 1 mg for 12 weeks.

Other Name: Azilect

Study Arm (s)

Active Comparator: Treatment Group
Intervention: Drug: Rasagiline
Placebo Comparator: Placebo Group
Intervention: Drug: Rasagiline/Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01497652

Other Study ID Numbers ^ICMJE

GUHIITCog2012

Has Data Monitoring Committee

Responsible Party

Georgetown University

Study Sponsor ^ICMJE

Georgetown University

Collaborators ^ICMJE

Teva Neuroscience, Inc.

Investigators ^ICMJE

Principal Investigator:

Fernando L Pagan, MD

Georgetown University

Information Provided By

Georgetown University

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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