"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 range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)