New York City, New York 10016


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).


Study summary:

The main aims of this study are: 1. To investigate whether in PDD and DLB th specific disturbances in the basal ganglia thalamocortical network, measured through the Electroencephalography (EEG) frequency analysis, are ameliorated by armodafinil. Our main hypothesis is that armodafinil can restore the attention and improve cognitive disturbances in PDD and DLB, through a specific effect on striatal-thalamo-cortical activity.


Criteria:

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


NCT ID:

NCT01256905


Primary Contact:

Principal Investigator
Sara Varanese, MD
NYU Parkinsons and Movement Disorders Center

Sara Varanese, M.D.
Phone: 212-263-4838 ext. 3
Email: sara.varanese@nyumc.org


Backup Contact:

Email: Jamika.Singleton-Garvin@nyumc.org
Jamika Y. Singleton-Garvin
Phone: 212-263-7042


Location Contact:

New York City, New York 10016
United States

Sara Varanese, M.D.
Phone: 212-263-4838
Email: sara.varanese@nyumc.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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