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

Withdrawn before enrolling · Not applicable

Conditions studied: Parkinsons Disease, Lewy Bodies Disease

In brief

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).

Key facts

Study ID

NCT01256905

Run by

NYU Langone Health

People needed

0

Starts

2011-01-01

Expected to finish

2011-08-08

Last updated by the study team

2021-08-23

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• NYU Parkinsons and Movement Disorders Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.