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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by New York University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cephalon
Information provided by:
New York University
ClinicalTrials.gov Identifier:
NCT01256905
First received: December 8, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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 Intervention
Parkinsons Disease
Lewy Bodies Disease
Drug: Armodafinil

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies

Resource links provided by NLM:


Further study details as provided by New York University:

Primary Outcome Measures:
  • EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Armodafinil
    Armodafinil 150 mg
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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256905

Contacts
Contact: Sara Varanese, M.D. 212-263-4838 ext 3 sara.varanese@nyumc.org
Contact: Jamika Y. Singleton-Garvin 212-263-7042 Jamika.Singleton-Garvin@nyumc.org

Locations
United States, New York
NYU Parkinsons and Movement Disorders Center Recruiting
New York City, New York, United States, 10016
Contact: Sara Varanese, M.D.    212-263-4838 ext 3    sara.varanese@nyumc.org   
Contact: Jamika Y Singleton-Garvin    212-263-7042    Jamika.Singleton-Garvin@nyumc.org   
Principal Investigator: Sara Varanese, M.D.         
Sponsors and Collaborators
New York University
Cephalon
Investigators
Principal Investigator: Sara Varanese, MD NYU Parkinsons and Movement Disorders Center
  More Information

Additional Information:
No publications provided

Responsible Party: Sara Varanese, M.D., NYU Parkinsons and Movement Disorders Center
ClinicalTrials.gov Identifier: NCT01256905     History of Changes
Other Study ID Numbers: C10953/6268
Study First Received: December 8, 2010
Last Updated: December 8, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dementia
Parkinson Disease
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014