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{
  "id": "NCT00013650",
  "type": "Study",
  "data": {
    "briefSummary": "The purpose of this study is to evaluate the effects of the drug cyclophosphamide (CY) on inflammation and immune responses in individuals with Alzheimer's Disease (AD).\n\nInflammation and immunologic response appear to contribute to neurodegeneration in people with AD. In a process called gliosis, the brain immune cells microglia and astroglia undergo activation and possible proliferation, which promotes neuronal injury and death. Activated microglia and astroglia produce compounds that are cytotoxic to neurons, and they express molecules that greatly amplify immune and inflammatory processes in the brain. Excessive glial activation and proliferation are thought to be pivotal events that hasten the demise of synapses and neurons in AD. Fortunately, increased understanding of immune and inflammatory pathology in AD has provided new opportunities for designing disease-altering treatments for AD. Studies suggest that medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and immunomodulatory agents may have an important role in altering the course of AD. CY is a potent anti-inflammatory and immunomodulatory drug that inhibits proliferation of immune cells. This study will evaluate the effects of CY on individuals with mild to moderate AD.\n\nParticipants in this study will be randomly assigned to receive either two different doses of CY or placebo (an inactive pill) for 6 months. Participants who receive placebo during the 6 months will have the option of receiving CY for an additional 6 months. Participants will undergo magnetic resonance imaging (MRI) scans of the brain. Measures of cerebral spinal fluid biomarkers or neurodegeneration, neuroinflammation, and neuroimmune activation will be taken. In addition, peripheral lymphocyte subsets and peripheral markers of inflammation will be assessed.",
    "completionDate": "2008-04-21",
    "conditions": [
      "Alzheimer's Disease"
    ],
    "enrollmentCount": 60,
    "enrollmentType": null,
    "nctId": "NCT00013650",
    "phase": "PHASE1",
    "sponsorId": "national-institute-of-mental-health-nimh",
    "startDate": "2001-03-22",
    "status": "COMPLETED",
    "studyType": "INTERVENTIONAL",
    "title": "Pilot Study of Immunomodulatory Versus Antiinflammatory Therapy in Alzheimer's Disease",
    "url": "https://clinicaltrials.gov/study/NCT00013650"
  }
}