Alzheimer's drug study not done, expert says
A UH professor warns that deeming treatment ineffective would be premature
A University of Hawaii professor of psychiatry who participated in a national study of antipsychotic drugs used to treat Alzheimer's disease said he "wouldn't make a blanket statement" that they are not effective.
"And this is only Phase 1 results," said Dr. Iqbal "Ike" Ahmed, principal investigator for the research in Hawaii. The study had four phases, he pointed out.
The first phase showed commonly prescribed drugs used to treat Alzheimer's patients with delusions, aggression, hallucinations and similar symptoms appear to be no more effective than a placebo when considering adverse side effects.
The results were reported in yesterday's issue of the New England Journal of Medicine.
The Queen's Medical Center was one of 42 sites participating in the $16.9 million, five-year study.
Ahmed, associated with Queen's and the Hawaii State Hospital, signed up 14 patients for the study and followed each for nine months.
Most Asian patients in the study were in Hawaii, but there was no breakdown on how they compared with patients of other nationalities at other sites, Ahmed said.
Three drugs, all newer antipsychotic medications, were used in the first trial, as well as a placebo. Patients were given either one of the drugs or the placebo in the first phase, Ahmed said.
The blind study assigned the drugs or placebo randomly. Neither patients or doctors knew what drug a patient was given, or if it was a placebo, Ahmed said.
"If you take side effects into account, as well as effectiveness, from a practical standpoint, these drugs are not that useful clinically to take care of patients," he said.
They are helpful in reducing symptoms of agitation, he said. "But because of side effects, it sort of cancels out benefits."
About 26 to 32 percent of patients taking active medications improved, compared with 21 percent of those taking the placebo. However, the medications caused confusion, sedation and weight gain in some patients, it was reported.
Ahmed said the study was based on discontinuation of medications: "Why do doctors discontinue medicine? Basically there was no difference between these medications and placebos in discontinuation rates."
He said medications were discontinued mainly because of side effects, and placebos were discontinued mainly because they were not effective.
Patients who did not respond to the initial treatment were moved to the second phase of the study for a different drug or placebo, he said. If they did respond to the initial drug, they were kept on it for 36 weeks.
"There seems to be some differences among drugs, even now we can see, but we won't know until the study is completed," Ahmed said. Data from the other three phases will be released in the next year, he said.