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Nuplazid improves psychosis in patients with Alzheimer’s disease
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A phase 2 trial showed that Nuplazid significantly improved certain psychosis scores at 6 weeks in patients with severe psychosis related to Alzheimer’s disease, according to findings recently published in Lancet Neurology.
“Psychosis is a common and distressing symptom in people with Alzheimer’s disease. There are no licensed drugs for this indication. Current antipsychotics are used off label but have only very modest benefits and lots of adverse events including doubling mortality and increasing stroke threefold. A safe and effective treatment is a big unmet need,” Clive Ballard, MBChB, Institute of Health Research, University of Exeter Medical School, United Kingdom, told Healio Family Medicine.
For their phase 2 trial, researchers randomly grouped 181 nursing home patients likely to have psychosis related to Alzheimer’s disease in a 1:1 ratio to receive two 17-mg tablets of Nuplazid (pimavanserin, Acadia Pharmaceuticals) per day or placebo. The mean Neuropsychiatric Inventory–Nursing Home baseline scores were 9.5 for those receiving pimavanserin (mean age, 85.6 years) vs. 10 for those receiving placebo (mean age, 86.1 years).
Ballard and colleagues found that mean change in those scores at week 6 was –3.76 points (standard error = 0.65) for patients receiving pimavanserin vs –1.93 points (standard error = 0.63) for patients receiving placebo (mean difference –1.84; 95% CI, –3.64 to –0.04) However, by week 12, no significant advantage was seen in those taking pimavanserin compared with those taking placebo was seen in the overall study population (treatment difference –0.51; 95% CI, –2.23 to 1.21).
In addition, common adverse events in both groups included falls, UTIs and agitation. Eight patients receiving pimavanserin vs. 11 receiving placebo stopped treatment due to these adverse events. Also, neither group saw changes in motor function or cognition.
“It’s particularly encouraging that most benefit was seen in those with the most severe psychotic symptom, as this group is most likely to be prescribed antipsychotics,” Ballard said in a press release.
Ballard told Healio Family Medicine that a phase 3 trial exploring pimavanserin providing a “sustainability of benefit” for patients with Alzheimer’s disease and psychosis should be complete within 18 to 24 months. – by Janel Miller
Disclosure: Ballard reports grants and personal fees from ACADIA and Lundbeck, personal fees from GlaxoSmithKline, Heptares, Lilly, Otsuka, Orion, Pfizer and Roche. Please see the study for the other authors relevant financial disclosures.