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Drugs Aimed at Troublesome Alzheimer’s Symptoms Work for Some, Not Most

Wednesday, October 11, 2006

The medications that doctors most often turn to when treating Alzheimer’s patients who are aggressive or agitated work for some patients but aren’t effective enough to be used broadly, say physicians who conducted the largest study yet to look at their effectiveness.

Doctors commonly use the medications, known as atypical antipsychotics, to treat schizophrenia and bipolar disorder. Many doctors also use them to treat the symptoms of Alzheimer’s disease that are among the toughest for families and caregivers to deal with – psychiatric symptoms like hallucinations and behaviors such as slapping, kicking, yelling, and wandering. Since there are no medications approved by the Food & Drug Administration to treat these symptoms in patients with dementia, doctors sometimes try medications that treat the same symptoms in other patients.

In the study published in the Oct. 12 issue of the New England Journal of Medicine, doctors at the University of Rochester Medical Center and 41 other sites across the nation report that the beneficial effects of such medications come with side effects that generally aren’t worth the trade-off for most patients.

“Every individual patient is unique, and doctors must tailor their treatment carefully to that patient,” said M. Saleem Ismail, M.D., assistant professor of Psychiatry, one of the authors of the study. “Some patients do benefit.”

The five-year study funded by the National Institute of Mental Health included a total of 421 people, including 29 in Rochester, where more people took part than at any other site in the nation. Participants had Alzheimer’s-related dementia with additional symptoms such as delusions, aggression, hallucinations, or agitation that were severe enough to disrupt their functioning. The study was aimed at patients who either lived with a family member or caregiver at home, or resided in assisted living facilities.

Participants in the study received either a placebo or one of three atypical antipsychotics: olanzapine (Zyprexa), quetiapine (Seroquel), or risperidone (Risperdal). Doctors judged each medication’s overall benefits and risks by measuring how long a patient stayed on the medication before discontinuing it for any reason.

While some participants did benefit from the treatment, the medications were often associated with troubling side effects, such as sleepiness, confusion, and weight gain.

“Antipsychotic medications have been used extensively for Alzheimer’s patients without enough solid evidence of whether they are effective,” said NIMH Director Thomas R. Insel, M.D. “The study has vital public health implications because it provides physicians and patients with information to more accurately weigh the medications’ benefits against their drawbacks, with the needs and unique reactions of their individual patients.”

Ismail says the study results reinforce what many doctors and nurses know: Patients with dementia must be evaluated thoroughly before any treatment with medication.

“The burden is really on the doctor to do a very careful, thorough evaluation,” says Ismail, who was the medical monitor for the study and approved which patients took part. “There are a number of things that might be upsetting the patient. They might have medical issues like hearing problems or cataracts. Or there may be environmental issues, and something as simple as turning down the volume on the TV might help. And because they have dementia, they have difficulty expressing these things. These need to be addressed before medication is considered.”

The study aims to address one of the most vexing problems of Alzheimer’s disease: behaviors like aggression and agitation that are unpleasant for patients and upset family members and caregivers, often causing families to decide that a patient needs around-the-clock care in a nursing home. More than three of every four patients with the disease have such behavior at some point during their illness.

“If we could prevent or treat these aggressive behaviors, that could translate into some patients not going into a nursing home as quickly as they otherwise would,” said Ismail.

The study was unique in many ways. Its focus was on patients who were still living at home, the home of a caregiver, or at an assisted-living facility; most other studies of aggressive behaviors in patients with Alzheimer’s have taken place in nursing homes. The study took into account the ways that doctors often prescribe medications in a real-world setting, which is rarely as pristine as a pure research setting. Doctors also consulted caregivers about the health of their loved ones and took that input into consideration. In an editorial in NEJM, Jason Karlawish, M.D., of the University of Pennsylvania, called the study “an exemplar of the clinical trial’s revolutionary role in shaping therapeutics” and “a model for how to spend our taxes on research.”

In addition to Ismail, other University of Rochester doctors who took part in the study were Pierre Tariot, M.D., now at the Banner Alzheimer’s Institute in Phoenix, Az., and Michael Ryan, M.D., now at Merck Inc. The University played a leading role in the study nationally – Tariot helped design the study, and Ismail served as medical monitor.

The study was done through the University’s Program in Neurobehavioral Therapeutics, based at Monroe Community Hospital. More people have taken part in Alzheimer’s studies there than at any other site in the nation, according to figures from the Alzheimer’s Disease Cooperative Study group, the premier collection of scientists nationwide who work together to test new treatments for the disease. University scientists are currently conducting about a dozen studies of new ways to prevent or treat the disease.

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