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

Conditions:Parkinsons Disease, Neurology
Therapuetic Areas:Neurology
Age Range:50 - 80
Start Date:December 2010
Contact:Sara Varanese, M.D.

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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).

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

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

- 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
We found this trial at
New York City, New York 10016
New York City, NY
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