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Trial record 19 of 63 for:    DEMENTIA, LEWY BODY

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by New York University.
Recruitment status was:  Recruiting
Information provided by:
New York University Identifier:
First received: December 8, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
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).

Condition Intervention
Parkinsons Disease Lewy Bodies Disease Drug: Armodafinil

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies

Resource links provided by NLM:

Further study details as provided by New York University:

Primary Outcome Measures:
  • EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks) [ Time Frame: 2 hours ]

Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Armodafinil
    Armodafinil 150 mg
Detailed Description:

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.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01256905

Contact: Sara Varanese, M.D. 212-263-4838 ext 3
Contact: Jamika Y. Singleton-Garvin 212-263-7042

United States, New York
NYU Parkinsons and Movement Disorders Center Recruiting
New York City, New York, United States, 10016
Contact: Sara Varanese, M.D.    212-263-4838 ext 3   
Contact: Jamika Y Singleton-Garvin    212-263-7042   
Principal Investigator: Sara Varanese, M.D.         
Sponsors and Collaborators
New York University
Principal Investigator: Sara Varanese, MD NYU Parkinsons and Movement Disorders Center
  More Information

Additional Information:
Responsible Party: Sara Varanese, M.D., NYU Parkinsons and Movement Disorders Center Identifier: NCT01256905     History of Changes
Other Study ID Numbers: C10953/6268
Study First Received: December 8, 2010
Last Updated: December 8, 2010

Additional relevant MeSH terms:
Lewy Body Disease
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017