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Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies | Clinical Trials | Clareo Health

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

NCT01256905•NYU Langone Health

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 80 years

Sex

ALL

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

Locations (1)

NYU Parkinsons and Movement Disorders Center

New York, New York, United States

Key Dates

Start Date

January 1, 2011

Primary Completion Date

August 8, 2011

Completion Date

August 8, 2011

Last Updated

August 23, 2021

Conditions

Parkinsons DiseaseLewy Bodies Disease

Interventions

Armodafinil

DRUG

Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

NCT06821230

MindfulnessCaregivers+5 more

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RECRUITING

Udall Project 1 Aim 4

NCT05568199

Parkinsons DiseaseDeep Brain Stimulation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

Udall Project 1 Aim 4

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