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

NCT01497652 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-12-16

No results posted yet for this 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.

Conditions

Interventions

DRUG

Rasagiline/Placebo

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

DRUG

Rasagiline

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

Sponsors & Collaborators

  • Teva Neuroscience, Inc.

    collaborator INDUSTRY
  • Georgetown University

    lead OTHER

Principal Investigators

  • Fernando L Pagan, MD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497652 on ClinicalTrials.gov