The U.S. government launched a national plan to address Alzheimer's disease on Tuesday with funding for a first prevention study in high-risk patients and tests on an insulin nasal spray that has shown promise in earlier studies.
The trials, funded by grants of $16 million and $7.9 million respectively, are initial steps in the National Alzheimer's Plan, a sweeping effort to find an effective way to prevent or treat Alzheimer's by 2025 and improve the care of those already afflicted with the brain-wasting disease.
"This is our roadmap that will help us meet our goal to prevent and effectively treat Alzheimer's disease by 2025," Human Services Secretary Kathleen Sebelius told scientists at an Alzheimer's summit at the National Institutes of Health in Bethesda, Maryland.
"The goal of the new law is to give us the kind of clear, national focus and attention on Alzheimer's that we've given to other diseases," Sebelius told the meeting, which was relayed by webcast, referring to the National Alzheimer's Project Act signed by President Barack Obama last year.
Experts predict that without more effective drugs, the number of Americans with Alzheimer's will double by 2050 and annual related healthcare costs could soar to more than $1 trillion.
The fatal form of dementia affects about 5.1 million Americans today and current treatments address symptoms, but cannot prevent the disease or stop its progression.
Sebelius said progress had so far proven elusive.
"We've yet to harness the right formula for drug development and clinical-trial results continue to be disappointing," she said. "We've yet to find effective treatments or proven ways to prevent Alzheimer's disease, and that's the ultimate goal."
Among the immediate actions will be funding for a study involving an antibody drug that attacks amyloid -- a protein thought to be a cause of Alzheimer's -- in an international study of people who are genetically predisposed to develop the disease early.
The second will test the use of an insulin nasal spray to restore memory in patients with Alzheimer's.
An earlier, small study of the latter approach by Suzanne Craft of the University of Washington published last year showed memory improvements in people with mild to moderate Alzheimer's or a pre-Alzheimer's condition called amnestic mild cognitive impairment.
Funding for the new initiatives will come from $50 million the Obama administration has set aside for the National Alzheimer's Plan for fiscal 2012.
Another $100 million has been earmarked for fiscal 2013, including $80 million for research, $4.2 million for public awareness, $4 million for provider education, $10.5 million in caregiver support, and $1.3 million to improve data collection.
The national plan, called for in the National Alzheimer's Project Act signed by President Barack Obama last year, and drafted by the Department of Health and Human Services (HHS), reflects the input of 3,600 people or organizations.
"The plan addresses every aspect of what it is to confront Alzheimer's disease," Sebelius told scientists at the summit.
It includes development of new training for doctors, a public education campaign, including TV advertisements and a website -- www.alzheimers.gov -- to help families and carers find services and support.
Dr. R. Scott Turner of Georgetown University Medical Center's Memory Disorders Program applauded the announcement.
"These steps offer a ray of hope for those affected by Alzheimer's," Turner said. "We need a robust awareness campaign specifically targeting participation in research studies."
He said many clinical trials were moving at a glacial pace because of a lack of study volunteers nationwide.
"We need more people with Alzheimer's disease and their families to consider participating in research," he said.
Sebelius said the plan was a national one, not a federal one, because it would require efforts from both public and private sectors to address the burden of Alzheimer's disease.
"This is a strong plan that promises important progress when implemented," said Harry Johns, president and chief executive of the Alzheimer's Association. "For all Americans - not just the more than 5 million living with Alzheimer's and their 15 million caregivers today - this plan is an historic achievement."
Some have criticized the 2025 goal for a treatment as being too ambitious given the state of the science, and it was the subject of lengthy debate in the advisory council tasked with helping to write the national plan.
"We had people saying it was overly ambitious and we had people who said it wasn't ambitious enough," said Don Moulds, principal deputy assistant secretary for planning and evaluation at HHS, in a telephone interview.
Moulds said there was concern that an earlier goal might skew research funding into treatments that might be easy hits, but not game-changing treatments. In the end, the 2025 target was the earliest date a significant treatment could be found.
Although work was already going on to find a treatment for Alzheimer's, Moulds said the national plan and its specific targets and timelines would help focus the government's efforts.
"It's a huge initiative and a very ambitious step in the right direction," he said.