The federal government has gotten serious about fighting Alzheimer's disease.
Dual announcements this week, of an ambitious federal plan to stop the progress of the disease by 2025, and of a promising new clinical trial, were hailed as major steps for a nation that already has 5.5 million Alzheimer's sufferers, a number projected to triple by 2050. Secretary for Health and Human Services Kathleen Sibelius unveiled the National Plan to Address Alzheimer's Disease on May 15, as part of the Alzheimer's Disease Research Summit hosted by the National Institute on Aging, a branch of the National Institutes of Health.
George Vradenburg, chairman of the advocacy network USAgainstAlzheimer’s, has been among those leading a charge for the federal government to launch a program to fight Alzheimer's on the scale of previous efforts to eradicate polio and fight HIV/AIDS and cancer. He was also a member of the council which advised Sibelius on the administration’s plan. “They became persuaded that Alzheimer’s was not only a health challenge," Vradenburg says, "but also a fiscal challenge because of the cost of caring for people with the disease, and, longer term, a competitive challenge as well because of the drain on the workforce of caregiving burdens for those with a parent or spouse with the disease.”
“People should be very pleased that this disease, and the suffering of families, is a now a national priority,” Vradenburg says. “While there is now a goal to stop the disease by 2025, there is also an increase in attention to mobilizing the health-care system to be better prepared and to better execute support for families experiencing this disease. Those clinical trials are obviously going to take some time."
New Hope for Those Most Likely to Get Alzheimer's
The federal plan includes an immediate $50 million investment from the NIH in especially promising research. Part of that money will go toward a five-year, $100 million clinical trial also announced on May 15, and set to begin in 2013. This first-of-its-kind trial will focus on people whose genes virtually ensure that they will eventually develop the disease, but who do not yet show symptoms. Many subjects will take Crenezumab, a drug designed to prevent symptoms of Alzheimer's from occurring. (Some will take a placebo.) If it works, it could be a gateway to treatments to prevent the disease in others.
About 300 members of an extended family in Colombia who carry a genetic mutation predisposing them to early-onset Alzheimer's will be part of the clinical trial. Members of the family often show signs of the disease by age 45 and experience full dementia by 51. Family members in the study will be as young as 30, according to the NIH, which will partner in the trial with the Banner Alzheimer’s Institute in Phoenix, and with Genentech, the American pharmaceutical company that manufactures the drug. A smaller number of subjects living in the United States who have similar genetic mutations will also be included in the trial, whose leaders hope to see some positive results in subjects in as soon as two years through memory, cognition and emotional tests as well as PET scans, M.R.I. scans and spinal fluid tests.
“Because of this study, we do not feel as alone,” family member Gladys Betancur, 39, told The New York Times. Betancur has had a hysterectomy so that she cannot pass the mutation on to another generation. “Sometimes we think that life is ending, but now we feel that people are trying to help us.” (You can read an earlier Times report on the extended Colombian family here.)
The trial is unusual in that it targets healthy people in a developing country, but in interviews this week, study leaders said ethical concerns were trumped by the fact that the subjects were virtually guaranteed to get Alzheimer's unless the new treatment can prevent its onset. The Colombians call the disease La Bobera, or "the foolishness." In other trials of Crenezumab in the United States, Canada and Europe, the drug has not caused harmful side effects in test subjects.
A second trial being supported with immediate financing from the new federal action plan will test whether inhaled insulin can have an effect on mild cognitive impairment. In a smaller, earlier study, such a nasal spray showed some improvement in people with mild to moderate cases of Alzheimer's.
Previous drug trials have not led to treatments with long-term success in treating Alzheimer's symptoms, but experts have long held out hope that drugs introduced before the disease begins to damage the brain could be more effective. “We should keep things in perspective," Vradenburg says. "We have had a number of failures of candidate drugs targeting people with mild to moderate symptoms of the disease. There is now a belief in the scientific community that there is so much damage already done to people with moderate symptoms of the disease that no medicine can slow or stop the progression.
“The positive news is that we now have tools available to discern the emergence of Alzheimer's disease well before symptoms appear and the ability to aim potent drugs at the disease before symptoms appear and either defer or stop the progression at its earliest stage.”
What You Can Do About Alzheimer's Now
Successful or not, the results of the new clinical trial, and any new treatments that emerge from it, are years away. “It’s not going to be a one-, two- or three-year effort," Vradenburg says. "It's going to be a seven-to-12-year effort.”
In the interim, he says, we should all continue to take preventative steps to ward off Alzheimer’s and related illnesses. “The risk factors for Alzheimer’s are the same as the risk factors for cardiovascular disease and diabetes," Vradenburg says. "The things that you do to maintain the health and quality of your heart and your metabolism will enable your body to defend against this disease.”
Vradenburg also urges people to take part in the clinical trials for Alzheimer’s treatments he expects to emerge in the next two to three years to test other drugs that could potentially stave off the disease before symptoms emerge. You can locate and learn how to take part in clinical trials from The Alzheimer's Association and NIH.
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