Corticolimbic Degeneration and Treatment of Dementia
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall purpose of this research is to determine if there is a relationship between your
      symptoms of Dementia of the Alzheimers type and changes in the size and shape of certain
      brain structures during combined Donepezil (Aricept®) and Memantine (Namenda®) treatment.
    

Detailed description: 
      In this study we will be using Memantine (Namenda®) in an investigational fashion with
      individuals with very mild to mild dementia. Donepezil (Aricept®) is approved by the Food and
      Drug Administration for the treatment of Alzheimers disease. Memantine (Namenda®) is
      currently approved by the Food and Drug Administration for moderate and severe dementia only.
      This study may be instrumental in the development of a new therapy for others with similar
      conditions, and to determine whether Memantine (Namenda®) will be helpful to individuals with
      very mild to mild dementia.

      Specific Aim 1. To determine what neuroanatomical measures are most strongly correlated with
      the progression of clinical and cognitive deficits in patients with dementia of the Alzheimer
      type (DAT). To accomplish this aim, we will use high-resolution magnetic resonance (MR)
      imaging and the tools of computational anatomy to assess changes in the structure of selected
      subcortical (e.g., hippocampus) and cortical (e.g., parahippocampal gyrus and cingulate
      gyrus) structure along with clinical and cognitive measures of dementia severity in subjects
      with very mild-to-mild DAT. Specific Aim 2 - To determine whether cholinesterase inhibitors
      and memantine can slow disease progression in DAT subjects. To accomplish this aim, we will
      use MR imaging and the tools of computational anatomy to compare the rate of change in the
      neuroanatomical measures listed above in 1) untreated DAT subjects, 2) DAT subjects treated
      with donepezil alone, and 3) DAT subjects treated with the combination of donepezil and
      memantine.
    

Intervention name(s): Memantine (Namenda®); Donepezil (Aricept®)
Intervention type(s): Drug; Drug
Intervention description(s): Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.; 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.
Other intervention name(s): Namenda; Aricept
Intervention MeSH terms: Memantine; Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dementia of the Alzheimer type