The U.S. government has announced a major education and research campaign to fight Alzheimer's disease. As part of that effort, scientists are stepping up their efforts to develop drugs by the middle of the next decade that could prevent the incurable brain-wasting disease.
Two Alzheimer's disease prevention trials are receiving money from the National Institutes of Health, or NIH, as part of the Obama administration's new national strategy to fight the growing problem of Alzheimer's in the U.S. and around the world.
An estimated 5.4 million Americans suffer from Alzheimer's or some form of dementia. The number is expected to grow exponentially as the U.S. population ages, and reach 7.7 million by 2030. By then, Alzheimer's and other dementia disorders could be affecting as many as 66 million people worldwide.
The so-called National Alzheimer's Plan
calls on scientists to develop treatments to prevent the disease by 2025. NIH has set aside $50 million to help fund the effort. NIH director Francis Collins says the studies herald a new era in Alzheimer's disease research.
"We have learned more about this disease in the last couple of years than probably ever before," said Collins. "And now the goal is to take that and translate it into interventions."
Collins was speaking at an NIH-sponsored conference of the nation's top Alzheimer's researchers.
Scientists at the Banner Alzheimer's Institute in Arizona announced they will be conducting human trials early next year of an experimental drug, called crenezumab, that they hope will prevent the disease.
The study will involve members of a large extended family living in remote villages within several hundred kilometers of each other near Medellin, Colombia. Some of the thousands of relatives carry an extremely a rare genetic mutation that inevitably causes early on-set Alzheimer's.
Those with the genetic flaw begin showing cognitive declines in their mid-forties and are destined to develop full-blown Alzheimer's by their early 50's.
The Banner Institute's Pierre Tariot is one of the lead investigators. Addressing the ethical questions some critics have raised about testing drugs on healthy people in a poor developing country, Tariot says all of the study participants have been fully informed about the possibility that the drug might not work, or that they might get a placebo that does not contain crenezumab.
Tariot says they still wanted to participate.
"They have been faced with this devastating illness hitting every generation for hundreds of years," said Tariot. "As one of them put it, 'There are many rivers to cross but at least we are at the first bank.' And that's kind of the attitude that people have had."
Three hundred individuals have signed up for the trial; one-third will receive crenezumab and the others will be given a placebo. The trial will also include a smaller number of individuals in the United States.
If the therapy works in those with early-onset disease, scientists hope it may also help older individuals.
Cremezumab is a vaccine that targets the brain plaques or amyloid protein deposits that are thought to underlie development of Alzheimer's, according to Banner's Eric Reiman, who will help lead the study.
"Crenezumab is an antibody treatment that is intended to bind with amyloid and remove it from the brain," said Reiman.
Injections of crenezumab or placebo will be administered every two weeks.
The $100-million Colombia trial is slated to last five years, but researchers predict they could see results within two. NIH is providing $16 million to support the research; Banner is contributing another $15 million. The major share of the funding - about $65 million - will come from the drug's American manufacturer, Genentech.
A second Alzheimer's drug trial, also funded by NIH, has shown that a nasal insulin spray used twice daily by people with mild cognitive dysfunction seemed to improve their symptoms, offering hope that Alzheimer's could be treated or even prevented.