Impact of Armodafinil Therapy on Neuropsychiatric Features in Dementia with Lewy Bodies (S1.004)

Objective: Assess the effect of armodafinil therapy on neuropsychiatric features associated with dementia with Lewy bodies (DLB). Background: Common features of DLB are excessive daytime somnolence and neuropsychiatric features of visual hallucinations, agitation, apathy, delusions, depression, euphoria and anxiety. While wake-promoting agents have been shown to improve somnolence in this population, no data have been gathered on their effect on neuropsychiatric features. Design: We conducted a 12-week open label pilot study using armodafinil 250 mg taken orally to investigate its efficacy on daytime somnolence in patients with DLB as a primary endpoint. In this study, we report secondary efficacy endpoints related to neuropsychiatric morbidity. Caregivers completed an abbreviated measure of neuropsychiatric symptoms using the Neuropsychiatric Inventory (NPI) at baseline and after 1, 2, and 3 months of therapy. Last-Observation-Carried-Forward (LOCF) method was used to impute the few missing data. Results: Twenty subjects (16 male) median age 72 years completed all baseline assessments, of which 17 subjects completed the three month protocol. Overall neuropsychiatric morbidity improved after 1 month of armodafinil therapy (p=0.002), and total NPI scores also improved from baseline although not statistically significant. Specific neuropsychiatric features of visual hallucinations (p=0.001) and agitation (p=0.016) improved after 1 month of armodafinil therapy. The most notable NPI measure was apathy, with sustained improvement from baseline to months 1 (p=0.032), 2 (p=0.005), and 3 (p=0.006). No significant changes were noted in measures of delusions, depression, euphoria, or anxiety. Conclusions: Armodafinil therapy resulted in significant improvement of overall neuropsychiatric morbidity, visual hallucinations, and agitation early in the course of treatment. There was sustained improvement of apathy throughout the course of treatment. Our pilot study findings suggest improvement on some neuropsychiatric features of DLB with armodafinil. Open label results must be interpreted with caution due to absence of a control group. Funded by Cephalon, Inc. Disclosure: Dr. Kuntz has nothing to disclose. Dr. Mason has nothing to disclose. Dr. Lapid has nothing to disclose. Dr. Aakre has nothing to disclose. Dr. Lundt has nothing to disclose. Dr. Boeve has received personal compensation for activities with Isis Pharmaceuticals. Dr. Boeve has received research support from GE Healthcare and FORUM Pharmaceuticals.