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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01256905
Recruitment Status : Withdrawn (PI departure from institution)
First Posted : December 9, 2010
Last Update Posted : August 23, 2021
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
NYU Langone Health

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 Phase
Parkinsons Disease Lewy Bodies Disease Drug: Armodafinil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
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
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : August 8, 2011
Actual Study Completion Date : August 8, 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Armodafinil

Arm Intervention/treatment
Experimental: Armodafinil Drug: Armodafinil
Armodafinil 150 mg




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
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


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


Locations
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United States, New York
NYU Parkinsons and Movement Disorders Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Cephalon
Investigators
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Principal Investigator: Sara Varanese, MD NYU Parkinsons and Movement Disorders Center
Additional Information:
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01256905    
Other Study ID Numbers: 09-0189
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
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Parkinson Disease
Dementia
Lewy Body Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action