"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Single-Center Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies|
- Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
The MWT measures the subject's ability to stay awake while sitting quietly in a chair. The test has 4 parts, each lasting 40 minutes if the subject is able to remain awake that long each time, and the parts are spaced apart in 2 hour intervals through the day.
The subject is placed in a dim room, with the only source of light slightly behind the subject's head and out of his/her field of vision, and back and neck supported. During this time the subject is monitored with the same measures that are used in a standard overnight sleep study called a polysomnogram. The sleep latency, or time it takes the subject to fall asleep, will be recorded.
In healthy people, the time it takes to fall asleep may be approximately 30 minutes on the test. More than 97% of people will take eight minutes or longer to fall asleep. Therefore, sleep latency that is less than eight minutes is considered to be abnormal.
|Study Start Date:||November 2009|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
150-250 mg armodafinil by mouth daily
150-250 mg armodafinil by mouth daily
Other Name: Nuvigil
In patients with DLB, the following aims/objectives will be addressed by comparing data on key measures at baseline and at 4 and 12 weeks of therapy:
Primary Aims - to test the hypotheses that armodafinil therapy at 150-250 mg every morning:
- will result in improvement in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test (MWT) (Aim 1A)
- will result in improvement in the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) (Aim 1B)
- will result in improvement in the Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change (ADCS-CGIC) (Aim 1C)
- will be well-tolerated with no significant side-effects present (Aim 1D)
Secondary Aims - to test the hypotheses that armodafinil therapy at 150-250 mg every morning will result in improvement in:
- cognition as measured by the Mini-Mental State Examination (MMSE) and other focused neuropsychological tests (Aim 2A)
- neuropsychiatric morbidity, particularly apathy, depression, visual hallucinations, and delusions, as measured by the Neuropsychiatric Inventory (NPI) (Aim 2B)
- functional status as measured by the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Aim 2C)
- patient and caregiver quality of life (QOL) as measured by the linear analog scale (LASA) (Aim 2D)
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Bradley F Boeve, MD||Mayo Clinic|