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  »Alzheimer's Disease Neuroimaging Initiative (ADNI)
  »Telephone Interview of Cognitive Status (TICS)
  »Takeda Sleep Study
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Takeda Sleep Study

Why is this study being done ?
The purpose of this study is to evaluate whether Rozerem™ can safely improve sleep problems in persons with mild to moderate Alzheimer's disease. This drug has been FDA approved for insomnia but has not been tested in people with Alzheimer's disease. People with dementia from Alzheimer's disease often have disturbed sleep patterns characterized by lack of night time sleep and excessive daytime napping. Current medications for sleep problems in people with Alzheimer's disease are associated with an increased risk for falls along with changes in behavior, diminished physical activities, and slowed mental capacity. Rozerem™ is believed to help sleep by acting on parts of the brain that are thought to be invoved in maintaining the normal sleep-wake cycle. We hope to learn if Rozerem™ is helpful and safe for improving sleep in people with dementia from Alzheimer's disease.

What will participation in this study entail?
You will be asked to come to this center 8 times over the course of 8 weeks. The initial screening done during your first visit will involve a physical exam; record of your vital signs, height, and weight; ECG; blood test; and completion of a short questionnaire. In all subsequent visits, vital signs will be recorded, sleep diary collected and the study drug dispensed. Your blood will be tested at screening, on day 1, week 1, and every other week thereafter.

Who is eligible to participate in this study?

You can be eligible for this study if you are 55 years of age or older, are sleep disturbed, and have mild to moderate Alzheimer's disease.

How can I enroll in this study?
This study is currently enrolling volunteers. If interested, please contact:
Maya Slowinska (
University of Southern California Keck School of Medicine
Phone: (323) 442-7600

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