Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: 150-250 mg armodafinil by mouth daily
Eligibility criteria:
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
Patient is 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