The Triad Study (Avanir)

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.

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 uncontrollable crying/laughing associated with psuedobulbar palsy.

Study Length:

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.

Disorder/Condition:

Alzheimer's Disease and Agitation

Inclusion Criteria:

Potential subjects must be between 50-90 years old with clinically significant, moderate/severe agitation secondary to dementia of the Alzheimer’s type. The subjects must score between 6 – 26 on the Folstein (MMSE).

Study Title (brief):

The Triad Study (Avanir)

Study Description (brief):

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.

Study Contact:

Antero Sarreal, MD at 845-398-6532 or asarreal@nki.rfmh.org [2]