Phase 4 N=20 Treatment

"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"

Dementia With Lewy Bodies

Bottom Line

View on ClinicalTrials.gov: NCT01023672 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcome: Primary: Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT) — 7.0; 19.0 minutes — p=0.003

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Armodafinil (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)	7.0; 19.0	0.003 sig

Summary

This research study is to examine the effects of the study medication Armodafinil in patients with dementia with Lewy bodies (DLB). DLB is associated with memory and other thinking problems, excessive daytime sleepiness, hallucinations, delusions, apathy, and reduced quality of life. One type of medication that could potentially improve daytime sleepiness, memory and thinking skills, hallucinations, delusions, apathy, and quality of life is known as a wake-promoting medication. Armodafinil is a wake-promoting medication that has been developed for treatment of patients with narcolepsy, sleep apnea, and other disorders which cause excessive daytime sleepiness. The drug used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this drug/device in this research study. In this study, patients with DLB will receive daily oral Armodafinil tablets, and their response to treatment will be assessed over 12 weeks. This study does not involve any placebo medication, so all patients will receive Armodafinil treatment.

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) 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01023672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.