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

NYU Langone Health

Status

Withdrawn

Conditions

Lewy Bodies Disease

Parkinsons Disease

Treatments

Drug: Armodafinil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01256905

09-0189

Details and patient eligibility

About

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).

Full description

The main aims of this study are:

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.

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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