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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01256905
• Collaborator: Cephalon (Industry)
• Enrollment: 0
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 0

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Parkinsons Disease; Lewy Bodies Disease	Drug: Armodafinil	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Aug 8, 2011
• Actual Study Completion Date: Aug 8, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Armodafinil	Drug: Armodafinil; Armodafinil 150 mg

Outcome Measures

Primary Outcome Measures

1. EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks) [2 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Parkinsons and Movement Disorders Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• Cephalon

Investigators

• Principal Investigator: Sara Varanese, MD, NYU Parkinsons and Movement Disorders Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• armodafinil

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01256905
• Other Study ID Numbers: 09-0189
• First Posted: Dec 9, 2010
• Last Update Posted: Aug 23, 2021
• Last Verified: Aug 1, 2021

• Additional relevant MeSH terms: Parkinson Disease; Dementia; Lewy Body Disease; Modafinil

Study Results

No Results Posted as of Aug 23, 2021