Less Apathy in Patients With Lewy Body Dementia on Armodafinil

Pauline Anderson

April 20, 2016

VANCOUVER — The wakefulness-promoting agent armodafinil (Nuvigil, Cephalon) reduces apathy in some patients with dementia with Lewy bodies (DLB), results of a new study suggest.

But while armodafinil initially had a positive effect on other neuropsychiatric symptoms in patients with DLB, these improvements didn't last, lead author Bradley Boeve, MD, chair, behavioural neurology, Mayo Clinic, Rochester, Minnesota, reported.

Dr Boeve presented the new findings at the American Academy of Neurology (AAN) 2016 Annual Meeting.

In addition to having excessive daytime somnolence, patients with DLB often have recurrent hallucinations, anxiety, apathy, and agitation.

Less Potent

Armodafinil has largely dopinergic effects. It was selected as the wakefulness-promoting agent for the study because it has a good safety profile is less potent than standard psychostimulants (and so doesn't have some of the more bothersome side effects), said Dr Boeve.

The 12-week open-label pilot study included 20 patients with probable DLB (mean age, 72 years). They had been screened for significant untreated obstructive sleep apnea.

These patients were given oral armodafinil starting at 150 mg daily and going up to 250 mg daily. They were assessed at baseline, 1 month, 2 months, and 3 months. Seventeen patients completed the month 3 protocol.

The primary efficacy endpoint was score change on the Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test (MWT) from baseline to 3 months.

The study showed that for the ESS, most patients did better with treatment, "but a few did a bit worse," and there was a similar improvement in most patients on the MWT, Dr Boeve reported.

Pointing to two graphs showing progress on the two measurements over the 3 months, Dr Boeve said that a significant number of patients still had a score on both tests "in the abnormal range, so it did help, but hypersomnia continued" in some patients.

Caregivers completed an abbreviated measure of neuropsychiatric symptoms using the Neuropsychiatric Inventory (NPI) at baseline and after 1, 2, and 3 months of therapy.

The overall neuropsychiatric morbidity improved after 1 month (P = .002), and total NPI scores also improved from baseline, although not statistically significantly.

Similar 1-month improvements were found for visual hallucinations (P = .001) and for agitation (P = .016), but again, these improvements didn't hold up at 2 and 3 months.

However, apathy improved at month 1 (P = .032), and this was maintained at month 2 (P = .005) and month 3 (P = .006). The result for apathy "was the most robust finding among the neuropsychiatric features," commented Dr Boeve.

Researchers found no significant changes in measures of delusions, depression, euphoria, or anxiety.

There was no difference in quality of life as rated by patients themselves, but there was some improvement in quality of life from the caregiver's perspective.

After the presentation, a meeting attendee commented that in his experience, "some patients swear by this drug and others notice no effects."

"That's exactly our experience," noted Dr Boeve.

Lead author Karen Kuntz, Alzheimer's Disease Research Study coordinator, Mayo Clinic, later commented that the advantages of having a patient with DLB who is less apathetic are that "they are more involved in the day-to-day activities of their families, themselves, and their spouse" or partner.

The study did not pick up factors that may predict which patients might benefit most, said Kuntz.

"We saw a significant improvement in apathy and transient changes only in hallucinations, and agitation. But as Dr Boeve pointed out, the Epworth Sleep Scale and the MWT improved from baseline to the end of treatment. In those two measures, there was improvement, but not dramatically."

The study was funded by Cephalon Inc. Karen Kuntz has disclosed no relevant financial relationships. Dr Boeve disclosed a relationship with GE Healthcare.

American Academy of Neurology (AAN) 2016 Annual Meeting. Abstract I9.003. Presented April 19, 2016.

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