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

Last updated: December 15, 2015
Sponsor: Georgetown University
Overall Status: Completed

Phase

4

Condition

Parkinson's Disease

Memory Problems

Dementia

Treatment

N/A

Clinical Study ID

NCT01497652
IIT-TN-067
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women aged 40 or older with idiopathic Parkinson's disease on stabledopaminergic therapy for at least 1 month. The UK Brain Bank Criteria will be used toestablish the diagnosis of Parkinson's disease. Women must be post menopausal or agreeto avoid pregnancy. Modified Hoehn & Yahr staging < 3 and MoCA score must be greaterthan 21 but less than 28. Geriatric Depression Scale (GDS) is a sensitive and specificscreen for depression in the Parkinson's disease population. GDS scores of < 5 will beincluded in the study.

Exclusion

Exclusion Criteria:

  • Patients with secondary dementia, severe depression and atypical Parkinson's syndromesor Parkinson's plus will be excluded from the study. Patients on acetylcholineesterase or NMDA inhibitor medication will be excluded from the study. Patients withhistory 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. Individualsusing meperidine, and tramadol will be excluded. Patients with congestive heartfailure or myocardial infarction will also be excluded to avoid vascular dementia.

Study Design

Total Participants: 34
Study Start date:
January 01, 2012
Estimated Completion Date:
March 31, 2015

Connect with a study center

  • Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

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