Alzheimer’s study hits recruitment roadblock
Those who have or are likely to get Alzheimer’s may not want to know it.
The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s, or A4, study is the first to try to prevent memory loss by identifying and treating people whose brains show the earliest changes related to the disease but years before they begin to lose cognitive function.
Volunteers aged 65 to 85 will be screened for the presence of amyloid plaque, a protein found in the fatty membrane surrounding nerve cells, that builds up in the brain as people age and seems to be connected to Alzheimer’s. If successful, the trial could significantly curtail the disease, which currently afflicts 5 million Americans and is projected to affect 16 million by 2050.
Researchers at 60 sites across the U.S. and in Canada and Australia are seeking up to 10,000 volunteers to be screened for the 39-month trial, which is sponsored by the National Institutes of Health, the pharmaceutical company Eli Lilly and others.
“Everyone’s putting their bets on this horse,” said Scott Turner, director of the Memory Disorders Program at Georgetown University, one of the participating sites.
Recruiting began two months ago and is underway at 14 sites; by September, all 60 sites will be screening volunteers until 1,000 are found who are eligible.
But several sites have already expressed concern about being able to get enough volunteers. So far, just 500 people have expressed interest nationally and 50 are in the screening process.
Despite intensive recruiting, just five people have been scheduled for screening at Turner’s site in Washington, and only one has begun screening.
“We’re worried that we’re not going to be able to recruit at the rate we’re hoping to,” Turner said. “People may not want to know, because there are just not good treatments out there now.”
The stakes are high. The Alzheimer’s Association notes that the disease, which by one estimate is now the third leading cause of death in the United States, is projected to cost $214 billion this year - and that does not include the unpaid caregiving by family and friends that is valued at more than $220 billion. Alzheimer’s research has also been historically underfunded and has therefore proceeded more slowly than that into some other diseases.
The financial and emotional toll would be significantly reduced if the disease’s progress can be halted before symptoms begin, said Keith Fargo, director of scientific programs and outreach at the Alzheimer’s Association.
“This is becoming a very active area of research, to look earlier in the disease process,” he said, noting that there are other trials in the planning process that also focus on pre-symptomatic people. “We’re trying to get to the . . . place with Alzheimer’s where we don’t wait for the onset of dementia.”
The A4 Study’s requirements set a particuarly high bar for volunteers. Those who have the plaque buildup must pass health requirements and cognitive tests to qualify. Part of the screening also includes ensuring that participants are psychologically prepared to receive the distressing news that they have amyloid buildup.
Half of the 1,000 who enroll will receive a placebo and half will receive the drug solanezumab, which researchers hope will flush out the amyloid before it can build up enough to cause cognitive problems. If it is shown to be effective, all participants will be given the drug at the end of the trial.
“I think if this trial works, it really will shift the way we think about Alzheimer’s research,” making it more like HIV, diabetes, heart disease and other diseases that can be prevented before they become catastrophic, said Reisa Sperling, a Harvard Medical School neurology professor and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital and Massachusetts General Hospital, who is leading the trial.
In an add-on to the trial funded by the Alzheimer’s Association, an additional 500 people who don’t have the buildup will be studied to watch their progression over the same period.
Solanezumab was not effective in earlier trials with people who already had full-blown Alzheimer’s, but it did have promising effects on the mildest cases, leading researchers to believe it could work at pre-symptomatic stages.
But the trial has another significant recruiting challenge: unlike many trials, whose participants tend to be overwhelmingly white and highly educated, this one requires that at least one-fifth come from underrepresented groups such as African Americans and Latinos, who generally make up only 5 percent of clinical trials.
“I’ve gotten a lot of pushback from sites saying, ‘We can recruit but we’re not sure we can get you that one-fifth,’ “ Sperling said, adding that if a particular site is not able to come up with enough diversity among its recruits, it may be put on hold.
For the A4 Study, recruiters are turning to churches and universities with large minority populations to spread the word.
More studies on pre-symptomatic people are expected in the future, but they, too, may have a harder time recruiting people, said Laurie Ryan, director of the Alzheimer’s disease clinical trials program at the National Insitutes of Health and head of its dementias of aging branch. Ryan said she hopes those who have seen the disease up close will be moved to volunteer.
“For people who’ve had this experience in their own families, I do think there’s a motivating factor,” she said. “People are very worried about getting dementia and losing their cognitive functioning.”
Margaret Woodley-Krug, 65, a school librarian in Waldorf, Maryland, is one of them. She volunteered to be screened at Georgetown because her mother, who lives with her, has dementia.
“It’s frightening when you see a loved one not their self - they’re just a shell of what they used to be,” she said. When she mentioned to her doctor that she was afraid of the same thing happening to her, he told her about the trial.
Participating would make her feel she was doing some good for others and perhaps even for her own children, Woodley-Krug said.
“My friend was saying, ‘How could you do it, I wouldn’t want to know,’ “ she said. “But personally I’m the type of person that if I have the possibility I would rather know so I can prepare . . . It’s like that Dylan Thomas poem about going gently into the night - I’d rather rage, rage.”
- Abortion bill requires docs to help fetus live 5/12/15
- Measles vaccine may have other benefits 5/8/15
- CDC plans bird flu vaccine for humans 4/22/15
- Dog flu: What should you do? 4/22/15
- 'Dr. Oz’ to mount defense against critics 4/18/15
- Study links childrens’ brain sizes to affluence 4/16/15
- Type 2 diabetes, depression boost dementia risk 4/16/15
- Cure for baldness might be plucking hair out 4/11/15
Our new comment system is not supported in IE 7. Please upgrade your browser here.