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

NCT ID: NCT01256905

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2011-08-08

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.

Conditions

Parkinsons Disease; Lewy Bodies Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Armodafinil

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

Armodafinil 150 mg

Interventions

Armodafinil

Armodafinil 150 mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Varanese, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Parkinsons and Movement Disorders Center

Locations

NYU Parkinsons and Movement Disorders Center

New York, New York, United States

Countries

United States

Related Links

http://parkinson.med.nyu.edu/

armodafinil

Other Identifiers

09-0189

Identifier Type: -

Identifier Source: org_study_id