"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
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.