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

NCT01256905 | Withdrawn

• 1 other identifier: 09-0189
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinsons Disease; Lewy Bodies Disease

Outcome Measures

Primary Outcomes (1)

• EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks)

  2 hours

Study Arms (1)

Armodafinil

EXPERIMENTAL

Drug: Armodafinil

Interventions

Armodafinil DRUG

Armodafinil 150 mg

Armodafinil

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Cephalon: collaborator

Study Sites (1)

NYU Parkinsons and Movement Disorders Center

New York, New York, 10016, United States

Location

Related Links

• armodafinil

MeSH Terms

Conditions

Parkinson Disease

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sara Varanese, MD

  NYU Parkinsons and Movement Disorders Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: January 1, 2011
• Primary Completion: August 8, 2011
• Study Completion: August 8, 2011
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

US (1)