Women are at greater risk for dementia. Joining clinical trials can help to speed the development of promising drugs.
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By Harvard Health Publications
Alzheimer’s disease is feared more than cancer, heart attack, or stroke, according to a recent survey of people 65 and older. The reason: cancer, heart disease, and stroke are treatable, but there is little that can arrest the progress of Alzheimer’s. That situation is changing. “There are now opportunities to do something, perhaps to reduce your own risk and also to help the next generation see Alzheimer’s disease as preventable,” says Dr. Reisa Sperling, professor of neurology at Harvard Medical School.
By “opportunities,” Dr. Sperling is referring to clinical trials of drugs designed to prevent Alzheimer’s from developing in people who have not yet shown symptoms of dementia. Earlier studies, which had disappointing results, tested drugs in people who already had memory loss or even advanced dementia. The reason to begin treatment earlier, she says, is that most successful drugs prevent a disease from occurring rather than arrest a disease that is already entrenched. Two recent advances have opened the possibility of identifying and treating people at risk who haven’t developed signs of Alzheimer’s—the availability of imaging that can detect amyloid plaques in the brain, and the development of drugs that reduce those plaques.
How studies can benefit women
As new drugs are developed, it’s important to test them in thousands of people to determine whether they are safe and effective. Clinical trials can provide the information to help the FDA decide which drugs should be approved for use.
“It’s critical to get a lot of women in these studies because they may be the ones we can help the most,” Dr. Sperling says. Women are twice as likely as men to develop the disease, in large part because we live longer. Women with the APOE4 gene, which increases the risk of developing Alzheimer’s, are three times as likely to get the disease as men who have that gene. And women are four times as likely as men to be the principal caregiver for someone who has Alzheimer’s.
To learn about Alzheimer’s studies and get information on participating, contact the National Institute on Aging at 800-438-4380 or visit A4Study.org or alzheimers.org. Several studies are listed below.
- The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (A4 study). Dr. Sperling is a lead investigator in this study of solanezumab, an antibody that helps remove amyloid from the brain, in people ages 65 to 85 with amyloid plaques but no symptoms of dementia. A thousand people will be chosen from 10,000 volunteers and randomly assigned to receive either solanezumab or placebo.
- The LEARN study. People who aren’t selected for the A4 study may be eligible for the LEARN study, in which 500 people will have memory tests and imaging tests. The researchers will compare the LEARN group to the placebo group in the A4 study to look for other factors that may contribute to cognitive decline or to resilience.
- The A5 study. People ages 60 to 85 who have plaques but don’t have dementia symptoms will be randomly assigned to get either a beta-secretase inhibitor—an oral drug designed to prevent additional amyloid plaques from developing—or placebo.
- The Amaranth Study. About 1,500 people ages 55 to 85 with early Alzheimer’s will be randomly assigned to take either a beta-secretase inhibitor or a placebo.
- NOBLE. Researchers are enrolling 450 people ages 55 to 85 with mild or moderate Alzheimer’s to get one of two different doses of T-817MA—a drug developed to protect brain cells against the toxic effects of amyloid—or placebo.