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  »Simvastatin
  »Myriad
  »Valproate
  »Alzheimer's Disease Neuroimaging Initiative (ADNI)
  »Telephone Interview of Cognitive Status (TICS)
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VALPROATE NEUROPROTECTION

Background and Significance
This study represents a novel clinical trial strategy designed to asses both prospective "prophylactic" therapy for psychopathology in Alzheimer's Disease (AD) and also to asses an approach that may alter several aspects of the pathophysiology of AD, thereby perhaps resulting in alteration of clinical progression of illness. Interpretation of these results will be supported by study of relevant biomarkers and imaging data.

What is the main objective of this study?
The main objective of this study is to determine in a randomized, placebo-controlled clinical trial whether chronic valproate therapy delays the emergence of agitation and/or psychosis in outpatients with probable Alzheimer's disease (AD) who have not experienced agitation and psychosis in their illness.

What is the secondary objective of this study?
The other objective of this study is to determine whether chronic valproate therapy delays the progression of cognitive and functional measures of illness.

How will the study be conducted?
This is a randomized, double-blind, placebo-controlled, parallel design study of valproate at target dose of approximately 10-12 mg/kg per day in outpatients with probable AD, treated for 24 months followed by a two month washout.

How many patients will be participating in the study?
A total of 300 patients will be recruited for the study with 15 patients from USC.

Who is eligible to participate in this study?
Men and women with a diagnosis of probable Alzheimer's disease age 50 years or older, weighing at least 40 kg, residing in the community at baseline. Additionally, patients have a Mini Mental State Exam (MMSE) score of 10-20 inclusive, who have not experienced agitation or psychosis since the onset of their illness and who do not require treatment with psychotropic medications with the exception of antidepressants used only for the treatment of depressive symptoms and limited use of sedatives for sleep.

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
(323) 442-7600
e-mail: mslowins@usc.edu



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