"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies" (NCT01023672) | Clinical Trial Compass
CompletedPhase 4
"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"
United States20 participantsStarted 2009-11
Plain-language 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.
Who can participate
Age range50 Years – 90 Years
SexALL
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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
* MMS…
What they're measuring
1
Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)