Status:
WITHDRAWN
Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Cephalon
Conditions:
Parkinsons Disease
Lewy Bodies Disease
Eligibility:
All Genders
50-80 years
Phase:
NA
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 co...
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) fre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01256905
Start Date
January 1 2011
End Date
August 8 2011
Last Update
August 23 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Parkinsons and Movement Disorders Center
New York, New York, United States, 10016