Clinical Trials

Inclusion Criteria

• Diagnosis of clinically possible or probable DLB using established criteria
• Age 50-90 inclusive
• Epworth Sleepiness Scale score of 8 or greater
• MMSE score between 10 and 26 inclusive
• No active medical disorder that could preclude participation in a drug treatment trial over a 12 week protocol
• Stable medication regimen over previous four weeks
• Absence of psychotropic medications at doses viewed by the clinician to be significantly impacting the patient's alertness during wakefulness
• Absence of clinically significant primary sleep-related breathing disorder causing sleepiness as demonstrated by polysomnography (PSG) [ie, no significant upper airway resistance syndrome (UARS), obstructive sleep apnea (OSA), nor central sleep apnea (CSA) as reflected by a combined respiratory disturbance index (RDI) <15] OR adequate documentation of efficacy of treatment for UARS, OSA, and CSA
• Caregiver that is with the patient at least 4 hours/day for at least 5 days per week
• Patient and caregiver willing and able to participate in all study-related procedures
• Capable of giving informed consent, or if appropriate, has caregiver capable of giving consent on the subject's behalf

Exclusion Criteria

• Does not fulfill criteria for clinically possible or probable DLB
• Age <50 or >90
• Women with intact uterus and not post-menopausal unless pregnancy test performed at screening is negative
• Epworth Sleepiness Scale score less than 8
• MMSE score <10 or >26
• Active medical disorder that could preclude participation in a drug treatment trial over a 52 week protocol, such as
  • Hypertension with BP readings exceeding 150 mm Hg systolic and 90 mm Hg diastolic
  • Hypersensitivity to modafinil, armodafinil, or any other conventional stimulants
  • Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease
  • History of left ventricular hypertrophy or mitral valve prolapse
  • History of chronic or paroxysmal atrial fibrillation, chronic or paroxysmal atrial flutter, ventricular fibrillation, or ventricular tachycardia
  • History of cancer over preceding 1 year (excluding squamous or basal cell carcinoma of the skin)
  • History of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS)
  • Pulmonary disease requiring oral or inhalatory medications
  • Any other medical disorder considered by the study physicians as inappropriate for any wake-promoting medication
• Medication regimen has not been stable over preceding four weeks
• Concurrent use of lamotrigine or oxcarbazepine
• Presence of over-the-counter and prescription psychotropic medications at doses viewed by the clinician to be significantly impacting the patient's alertness during wakefulness, such as
  • Clonazepam > 1 mg/night
  • Seroquel > 100 mg/night
  • Zyprexa > 10 mg/night
• Presence of another clinically-significant primary sleep disorder (eg, UARS, OSA, CSA) that is not being treated
• Clinically significant abnormalities on screening ECG or laboratory tests
• Patient or caregiver unwilling or unable to participate in all study-related procedures
• Caregiver is not with patient at least 4 hours/day for at least 5 days/week
• Patient or caregiver unwilling or unable to provide informed consent
• CT or MRI evidence of a clinically significant structural lesion that could account for the participants dementia