Clinical Trial Details

NCT ID: NCT01256905
Date Last Changed: December 8, 2010

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).

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Recruitment Details

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
Compensation

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
E-mail:

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