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

NYU Langone Health

Overview

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 activity.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Parkinsons Disease Lewy Bodies Disease

Interventions

ArmodafinilDRUG

Armodafinil 150 mg

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Parkinsons and Movement Disorders Center

New York, New York, United States

Outcomes

Primary Outcomes

EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks)

Time frame: 2 hours

Data from ClinicalTrials.gov

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