Open Label Trial of Armodafinil Shows Promise in DLB

June 21, 2012

June 12, 2012 - At the American Academy of Neurology's annual meeting in April,

researchers from the Mayo Clinic reported on a small clinical trial which

assessed the safety, tolerability and efficacy of armodafinil therapy for

excessive sleepiness (hypersomnia) associated with dementia with Lewy bodies

(DLB).

Twenty subjects were enrolled in this open label trial, with three individuals

who did not complete the trial due to worsening disease or death from

community-acquired pneumonia. Individuals in the study had mild to moderate

dementia and were already being treated with medications routine in DLB clinical

care for dementia, behavior, sleep and movement symptoms. Individuals were

treated for 30 days with 150 mg armodafinil to establish safety and tolerability

and were increased to 250 mg for an additional 60 days.

Mild to marked clinical improvement was observed in 90% of participants, with

moderate to marked improvement seen in 45% of participants. Improved caregiver

quality of life was reported as well. " The majority of patients experienced some

degree of improvement in key features associated with DLB, and most tolerated

the medication without significant side-effects, " said Dr. Brad Boeve who

directed the trial. " Yet some patients continued to experience significant

daytime sleepiness and other problematic DLB features. This medication should

obviously not be considered a cure for DLB, but it is another option for

clinicians and patients to consider as they work together in treating bothersome

symptoms associated with DLB – particularly excessive daytime sleepiness. "

Significant improvement over baseline was reported in the ability to maintain

wakefulness, and significant improvement was reported in apathy and improvement

occurred in visual hallucinations, delusions and anxiety, with the exception of

the 3 individuals who discontinued participation.

This data suggests treatment with armodafinil offers reasonable safety,

tolerability and improvements over baseline in excessive sleepiness in

individuals with DLB, and may reduce neuropsychiatric features as well.

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