Back to resultsAttention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies (Armodafinil)
Primary Purpose
Parkinsons Disease, Lewy Bodies Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Armodafinil
Sponsored by
About this trial
This is an interventional treatment trial for Parkinsons Disease
Eligibility 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
Sites / Locations
- NYU Parkinsons and Movement Disorders Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Armodafinil
Arm Description
Outcomes
Primary Outcome Measures
EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks)
Secondary Outcome Measures
Full Information
NCT ID
NCT01256905
First Posted
December 8, 2010
Last Updated
August 17, 2021
Sponsor
NYU Langone Health
Collaborators
Cephalon
1. Study Identification
Unique Protocol Identification Number
NCT01256905
Brief Title
Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies
Acronym
Armodafinil
Official Title
Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
PI departure from institution
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
August 8, 2011 (Actual)
Study Completion Date
August 8, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Cephalon
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsons Disease, Lewy Bodies Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Armodafinil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Armodafinil
Intervention Description
Armodafinil 150 mg
Primary Outcome Measure Information:
Title
EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks)
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Varanese, MD
Organizational Affiliation
NYU Parkinsons and Movement Disorders Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Parkinsons and Movement Disorders Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Links:
URL
http://parkinson.med.nyu.edu/
Description
armodafinil
Learn more about this trial
Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies
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