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

Parkinsons Disease Clinical Trial

— Armodafinil  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01256905
• Other study ID #: 09-0189
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2011
• Est. completion date: August 8, 2011

Study information

• Verified date: August 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 8, 2011
• Est. primary completion date: August 8, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Lewy Bodies Disease
• Lewy Body Disease
• Parkinson Disease
• Parkinsons Disease

Intervention

Drug:
• Armodafinil
Armodafinil 150 mg

Locations

Country	Name	City	State
United States	NYU Parkinsons and Movement Disorders Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks)		2 hours

External Links

•   armodafinil