"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"
Condition: Dementia With Lewy Bodies
MeSH terms: Dementia; Lewy Body Disease
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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)
    

Intervention name(s): Armodafinil
Intervention type(s): Drug
Intervention description(s): 150-250 mg armodafinil by mouth daily
Other intervention name(s): Nuvigil
Intervention MeSH terms: Modafinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dementia with Lewy Bodies; hypersomnolence; cognition; neuropsychiatric morbidity; quality of life