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Clinical Trial Details

Overview

Research Study Summary

A clinical trial to evaluate treatments using Armodafinil for patients with Parkinsons Disease or Lewy Bodies Disease

Research Study Title

Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies

Purpose

The purpose of this study is to evaluate if a drug commonly used to treat excessive day-time sleepiness, called armodafinil (Nuvigil), is also effective in improving the impairment in the attention commonly reported by patients with more advanced Parkinson's disease (PD) and Lewy body disease (LBD).

To Learn more
Gender

Both Male and Female

Age

50 to 80 Years

Overall Status

Recruiting

Lead Sponsor

New York University

Duration

4 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 50 Years to 80 Years

Inclusion Criteria:

  • Established criteria for diagnosis of PDD (Parkinsons Disease) {Emre M et al. Mov Disord 2007;22:1689-707} and DLB (Lewy Bodies Disease) {McKeith et al. Neurology 2005;65:1863-72}

  • Mini Mental State Examination (MMSE) score between < 24; and/or Dementia Rating

  • Scale-2 (DRS-2) score < 134;

  • Clinical Assessment of Fluctuation (CAF) > 4;

  • Stable anti-parkinsonian medication in the 4 weeks preceding the study

Exclusion Criteria:

  • Use of cognitive enhancers (Donepezil, Rivastigmine, Galantamine, Modafinil, Memantine) in the last 4 weeks:

Concomitant use of any medication contraindicated with modafinil/armodafinil; History of alcohol and substances abuse. Use of medications known to alter the normal EEG activity in humans during the study period (i.e. clonazepam) History of psychiatric disorders, other than depression and psychiatric complication of PDD and DLB

Site Locations (1)

Country State City Zip Facility and Contact
United States New York New York City 10016 NYU Parkinsons and Movement Disorders Center
Sara Varanese, M.D.
212-263-4838 ext. 3
sara.varanese@nyumc.org

Sara Varanese, M.D.
Principal Investigator

Contact

Sara Varanese, M.D.
212-263-4838 ext. 3

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01256905

Date Last Changed: December 8, 2010

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