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

Not Applicable

Withdrawn

• Conditions: Parkinsons Disease; Lewy Bodies Disease
• Interventions: Drug: Armodafinil

• Registration Number: NCT01256905
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Study Start: 2011-01-01
• Primary Completion: 2011-08-08
• Study Completion: 2011-08-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Armodafinil	Armodafinil	-

Primary Outcome Measures

Name	Time	Method
EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks)	2 hours

Trial Locations

Locations (1)

NYU Parkinsons and Movement Disorders Center; 🇺🇸 New York, New York, United States