The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the proposed study is to determine if the NMDA receptor antagonist memantine has a
      neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of brain
      NAA and magnetic resonance imaging (MRI) volumetric measures of hippocampal volume. In
      secondary analyses, we will determine if measures of clinical stabilization produced by
      memantine in the treatment of Alzheimer's disease (AD) parallels stabilization of MRS
      measures of brain NAA and MRI volumetric measures of hippocampal volume.
    

Detailed description: 
      Alzheimer's disease (AD) is the most common form of dementia. Currently, there are more than
      4 million individuals with dementia in the United States with at least 400,000 deaths
      annually. AD is a progressive, neurodegenerative disorder, characterized neuropathologically
      by widespread neuronal loss, presence of neurofibrillary tangles, and deposits of beta
      amyloid in cerebral blood vessels and neuritic plaques. Since the medial-temporal lobes,
      hippocampus, and association cortex are significantly impacted it is not surprising that the
      primary symptom of AD is a decline in cognitive functioning that leads to marked impairment
      in daily functioning. In particular, memory impairments, visuospatial decline, language
      difficulties, and loss of executive function are central cognitive symptoms of this illness.
      Behavioral disturbances such as agitation and hallucinations often accompany disease
      progression. The illness lasts approximately 7 to 10 years, with patients requiring total
      care in the latter stages. Thus, AD places a tremendous emotional and economic burden on both
      patients and their caregivers. Beyond a cure, therapeutic approaches which would alleviate
      the symptoms or delay progression could be of substantial psychological and economic benefit.
      Recent placebo controlled clinical trials have shown memantine to be efficacious in the
      treatment of patients with moderate to severe AD.

      The aim of the proposed study is to determine if the NMDA receptor antagonist memantine has a
      neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of brain
      NAA and magnetic resonance imaging (MRI) volumetric measures of hippocampal volume. In
      secondary analyses, we will determine if measures of clinical stabilization produced by
      memantine in the treatment of Alzheimer's disease (AD) parallels stabilization of MRS
      measures of brain NAA and MRI volumetric measures of hippocampal volume.
    

Intervention name(s): Memantine; Placebo pill
Intervention type(s): Drug; Drug
Intervention description(s): 10mg Memantine; 10mg placebo pill
Other intervention name(s): Namenda; placebo
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment