Two trials that looked at whether the omega-3 fatty acid DHA might treat or prevent Alzheimer’s disease have produced mixed results.

The studies were done because of “a long history of epidemiological studies that related fish consumption to cognitive function,” explained Bill Thies, chief medical and scientific officer of the Alzheimer’s Association. Fish is rich in DHA, but the research scheduled to be presented Sunday at the association’s annual meeting in Vienna, Austria, used DHA derived from algae.

An 18-month study of people with mild to moderate Alzheimer’s disease “did not show treatment benefit in the study population as a whole, and does not support use of DHA for treatment of Alzheimer’s disease,” said study author Dr. Joseph Quinn, an associate professor of neurology at Oregon Health and Science University.

However, Quinn added that there was “an encouraging analysis of a subpopulation of the larger study,” showing a slower rate of decline in mental function among those who did not have the e4 version of the APOE gene. That version is known to increase the risk of developing Alzheimer’s disease. Between 70 percent and 80 percent of people have that gene version, Quinn estimated.

Still, “we’re not prepared to conclude that e4-negative people should be on DHA,” Quinn said. “We don’t know a mechanism that would account for a benefit in e4-negative people and we don’t know if our exploratory analysis would be confirmed in future trials.”

His study, funded by the U.S. National Institute on Aging, included 402 people, average age 76, with a daily dietary intake of less than 200 milligrams a day. Some took 2,000-milligram DHA supplements while others took a placebo. All underwent standard tests of mental function over the 18-month trial. The slower rate of decline seen in e4-deficient participants did not reach statistical significance.

The second study was a six-month trial of 900 milligrams a day of DHA in 485 people, average age 70, who did not have Alzheimer’s disease but had mild complaints about memory loss. Those taking the supplement made fewer errors on one memory test.

That trial was funded by the Martek Biosciences Corp., which markets the DHA used in both studies.

The results indicate that DHA supplements are appropriate for “people who have very mild memory complaints, which applies to a large percentage of the population at this age,” said Karin Yurko-Mauro, associate director of clinical research at Martek Biosciences. “We’re not talking about a disease stage here.”

The company is “looking at the potential for more trials,” but is still evaluating data from the completed study, Yurko-Mauro said.

“The results are certainly interesting,” Thies said. “There was some improvement in memory. Then you can get into a debate about what the real-world benefit would be of that improvement in memory.”

What is needed, Thies said, is a major trial for people with no Alzheimer’s disease but some memory problems. “DHA is a great candidate for such a trial because it is a food supplement that is currently available,” he said.

Meanwhile, Thies said, “it is too early” to make a recommendation about use of DHA supplements to prevent loss of mental function. “You would want to see more information in normal people before you make a recommendation,” Thies said. “In high doses, DHA does have side effects, so you would want to see a benefit to justify the risk you are taking. We need more work for that.”

A gene that may offer a highly accurate prediction of the risk of developing Alzheimer’s disease and the age at which people will begin to show symptoms has been identified by U.S. researchers.

The TOMM40 gene may be the most highly predictive Alzheimer’s gene discovered so far, said the Duke University Medical Center research team, who found that the gene could predict the age of Alzheimer’s disease onset within a five- to seven-year window among people over 60.

The study was scheduled to be presented July 12 at the Alzheimer’s Association 2009 International Conference on Alzheimer’s Disease, held in Vienna, Austria.

“If borne out through additional research, a doctor could evaluate a patient based on age, especially among those over age 60, their APOE genotype and their TOMM40 status, to calculate an estimated disease risk and age of onset,” lead author Dr. Allen Roses, director of the Deane Drug Discovery Institute at Duke, said in a university news release.

In previous research, Roses found that apolipoprotein E (APOE) genotypes, particularly APOE4, are associated with increased risk and younger age of development of Alzheimer’s disease. APOE4 accounts for about 50 percent of late-onset cases of Alzheimer’s, but the cause of the remainder of cases hasn’t been known.

“It now looks fairly clear that there are two major genes — APOE4 and TOMM40 — and together they account for an estimated 85 to 90 percent of the genetic effect,” Roses said.

The Duke team is planning a five-year study of APOE genotypes and TOMM40, along with a drug trial to assess prevention or delay of Alzheimer’s disease onset.

A bacterial pathogen that causes sepsis and meningitis in newborns shuts down immune cell function to ensure its survival, a new study shows.

The findings about Group B Streptococcus (GBS) may help lead to new drugs for infectious diseases that affect about 3,500 newborns in the United States each year, said the researchers at the University of California, San Diego School of Medicine.

They found that GBS dupes the immune system into reducing production of antibiotic molecules.

“We have discovered that the bacteria have evolved to use a trick we call ‘molecular mimicry.’ Like a wolf in sheep’s clothing, GBS can enter our body without activating the immune cells that are normally programmed to kill foreign invaders,” Dr. Victor Nizet, a professor of pediatrics and pharmacy at UC San Diego, said in a news release.

The study appeared online July 13 in the Journal of Experimental Medicine.

In addition to causing infections in newborns, GBS is associated with serious infections in pregnant women, adult diabetics and the elderly.

Thousands of schizophrenia patients worldwide may have died because of safety restrictions on the use of the second-generation antipsychotic drug clozapine, a new study suggests.

Finnish researchers concluded that clozapine is associated with a lower death rate compared to other antipsychotics.

For this study, the researchers looked at the cause of death in about 67,000 schizophrenia patients in Finland between 1996 and 2006. They compared mortality rates associated with use of any psychotic drugs against no use of the drugs, and also compared mortality rates linked to the six most frequently used antipsychotic drugs with use of the first-generation antipsychotic perphenazine.

Although the use of second-generation antipsychotic drugs rose from 13 percent to 64 percent, the difference in life expectancy from age 20 between schizophrenia patients and the general population did not widen from 1996 (25 years) to 2006 (22.5 years).

Compared with current use of perphenazine, the highest risk for death was among patients taking quetiapine (41 percent higher) and the lowest was for clozapine (26 percent lower).

The study also found that long-term use (seven to 11 years) of antipsychotics in general is associated with about a 20 percent lower death rate than with no antipsychotic use.

The researchers said they were surprised that patients taking clozapine had the lowest death rate.

“Our results raise the issue of whether clozpaine should be used as a first-line treatment, because it seems to be the safest antipsychotic in terms of mortality and it is also the most effective,” wrote Professor Jari Tiihonen, University of Kuopio and Niuvanniemi Hospital, and colleagues. “However, clozapine is inexpensive, and hence it is unprofitable for the pharmaceutical industry to market compared with other second-generation antipsychotic drugs. Additionally, monitoring schedules are a drawback that would be encountered with heightened use of clozapine, and physicians and other hospital staff might therefore be reluctant to initiate clozapine treatment.”

The researchers suggest that restrictions on clozapine use were arbitrary. “Restrictions on use of clozapine and thioridazine have not been based on any evidence for their overall ratio of risk to benefit,” Tiihonen wrote.

“Our results suggest that these instructions and recommendations [except for blood monitoring] might have caused thousands of premature deaths worldwide in patients who have been exposed to other antipsychotic drugs, which might be associated with increased mortality. In our opinion, such restrictions and recommendations should be based on solid scientific evidence for the safety of drugs. This example underscores the need for large nationwide databases to be used for surveillance of drug safety,” they concluded.

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