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The study is open to:

  • both male and female subjects

  • aged 50-90 years

  • diagnosed with AD with clinically significant, moderate/severe agitation

  • The subjects must score between 6 – 26 on the Folstein (MMSE).

 

This clinical trial sponsored by AVANIR Pharmaceuticals has a double-blind and an open label-phase. This study will investigate the effectiveness of an experimental drug for the treatment of agitation in individuals with Alzheimer’s disease. Agitation is quite common in this patient population (includes the following types of behaviors: screaming, cussing, destroying objects, grabbing, fighting and pacing) and can be extremely distressing to the individual, the family, and caregivers and generally does not respond to conventional medications.

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The experimental drug that will be used in this study, dextromethorphan, is the active ingredient used in over-the-counter cough syrup medicines and of a medication which has been approved by the FDA for the treatment of incontrollable crying/laughing associated with pseudobulbar palsy.

The double-blind phase of the study will last 3 months and the Open-label extension phase of the study will last up to 12 months.

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For information about participation in the TRIAD study, please contact Dr. Antero Sarreal at 845-398-6532, or at Antero.Sarreal@nki.rfmh.org.

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For more detailed information about the study and study drug please click here.

The TRIAD Study - RECRUITING

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