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

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ClinicalTrials.gov Identifier: NCT01256905
Recruitment Status : Unknown
Verified April 2010 by New York University.
Recruitment status was:  Recruiting
First Posted : December 9, 2010
Last Update Posted : December 9, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Parkinsons Disease Lewy Bodies Disease Drug: Armodafinil

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : December 2010
Estimated Primary Completion Date : April 2011


Arms and Interventions

Intervention Details:
    Drug: Armodafinil
    Armodafinil 150 mg

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256905


Contacts
Contact: Sara Varanese, M.D. 212-263-4838 ext 3 sara.varanese@nyumc.org
Contact: Jamika Y. Singleton-Garvin 212-263-7042 Jamika.Singleton-Garvin@nyumc.org

Locations
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    sara.varanese@nyumc.org   
Contact: Jamika Y Singleton-Garvin    212-263-7042    Jamika.Singleton-Garvin@nyumc.org   
Principal Investigator: Sara Varanese, M.D.         
Sponsors and Collaborators
New York University
Cephalon
Investigators
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
ClinicalTrials.gov Identifier: NCT01256905     History of Changes
Other Study ID Numbers: C10953/6268
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Lewy Body Disease
Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Armodafinil
Modafinil
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