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

• Status: Withdrawn
• Trial end date: 2011-08-08
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University; NYU Langone Health
• Collaborator: Cephalon
• Treatments: Armodafinil; Modafinil

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