Researchers from the University of Southern California Keck School of Medicine in Los Angeles recruited 421 Alzheimer's patients to test whether or not they would receive the same benefits from placebo pills as from three drugs -- called atypical anti-psychotics -- commonly prescribed to treat aggression, delusions and hallucinations in Alzheimer's patients.
The researchers, led by USC geriatric psychiatrist Lon Schneider, randomly split the participants into two groups. The first received one of three atypical anti-psychotics -- Zyprexa, Seroquel or Risperdal -- for eight weeks, while the second group received a placebo pill for the same amount of time.
At the study's conclusion, the researchers found that because the patients taking the anti-psychotics experienced side effects of confusion, tremors, sleepiness and muscle stiffness, the drugs were no more effective than the placebo pills.
"The message is that nobody should get the drugs," Schneider said.
Though atypical anti-psychotics are not approved by the Food and Drug Administration to treat Alzheimer's symptoms, they are prescribed to more than half of Alzheimer's sufferers for just that purpose. A practice called off-label drug prescribing allows doctors to prescribe any FDA-approved medicine to treat any disease, as long as the drug has been deemed "safe" for a specific purpose. Once a drug is approved and on the market, the FDA cannot dictate how doctors use that medication.
Hugo Perez, spokesman for AstraZeneca -- which makes the atypical anti-psychotic Seroquel -- said, "We don't recommend using Seroquel for psychosis, aggression or agitation in Alzheimer's patients."
Last year the FDA put its most serious "black box" safety warning on all atypical anti-psychotics after the drugs were found to increase premature death in older patients with dementia. The drug also warns users of an increased risk of diabetes, though Bill Thies of the Alzheimer's Association says such warnings have not affected prescribing.
Kaycee Sink of Wake Forest University said the study -- the first big study of its kind that was not funded by drug company money -- is "disappointing" because Alzheimer's symptoms "are so hard to manage that caregivers often feel desperate."
Neurologist John Morris, director of the Alzheimer's Disease Research Center at Washington University in St. Louis, said, "Too often, these anti-psychotics get overused or misused. These drugs should be the last line of therapy, and they're for short-term use."
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