Dementia Clinical Trial
Official title:
Corticolimbic Degeneration and Treatment of Dementia
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.
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.
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