"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|
- Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test (MWT); Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog); Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change (CGIC); safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Mini-Mental State Examination (MMSE) and other focused neuropsychological tests; Neuropsychiatric Inventory (NPI); Activities of Daily Living (ADLs); Quality of life (QOL) [ Time Frame: 12 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Open label with active agent
150-250 mg 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 as measured by the linear analog scales (QOL-LASAs) (Aim 2D)