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US strategy for Alzheimer’s disease laid out

The US government today released its first strategic plan for battling Alzheimer’s disease, the progressive, incurable dementia that afflicts more than 5 million Americans.

Speaking at a large Alzheimer’s research summit on the campus of the US National Institutes of Health (NIH), Kathleen Sebelius, the US Secretary of Health and Human Services, called the 59-page National Plan to Address Alzheimer’s Disease “a blueprint for building on our research efforts” and “a road map that will help us meet our goal to effectively prevent and treat Alzheimer’s disease by 2025.”

Sebelius also promoted a new website that the department is launching as a “one stop shop” offering resources and support for patients with Alzheimer’s and their families and caregivers.

The plan was mandated by the National Alzheimer’s Project Act, which was signed into law by President Barack Obama in January 2011. The law directed a 25-member advisory committee to come up with the plan, which was released in draft form early this winter.  Nature published this interview with Ronald Petersen, the Mayo Clinic Alzheimer’s expert who heads the committee, shortly after the draft was released.

Today’s final plan, which deals with quality of care, community support and public awareness — in addition to research — is substantially unchanged from the draft, but that didn’t dampen enthusiasm on the NIH campus.

“We’re very excited about seeing how this exceptional moment can be utilized,” said Francis Collins, the NIH director.

The research elements in the plan are not surprising. They include suggestions that international research be coordinated to avoid duplication; that clinical trials on both prevention and treatment be expanded; and that trials include more ethnic and racial minorities.

Collins fleshed out how the NIH will use the US$50 million in current-year funds that it has redirected to research on Alzheimer’s as part of the administration’s new emphasis on the disease.  He and Sebelius had already announced the 2012 Alzheimer’s money in February, noting, as Nature reported then (see ‘Graying US boosts Alzheimer’s research‘)  that about $25 million will be used to sequence the genomes and exomes of people afflicted with Alzheimer’s and of unaffected individuals, to identify both risk factors and protective genetic variants.

Today, Collins announced that $7.9 million of the remainder will be spent on a five-year clinical trial of 240 participants with mild cognitive impairment and early Alzheimer’s Disease, to see if an insulin nasal spray can improve symptoms of impaired memory and cognition. Conditions such as diabetes, in which the body makes too little insulin or resists its effects, are associated with an increased risk of Alzheimer’s. A promising pilot study published in Archives of Neurology last year showed insulin improving both memory and cognition in affected subjects. The principal investigator for the clinical trial is Suzanne Craft at the University of Washington and the Veterans Affairs Puget Sound Health Care System in Seattle.

The biomedical agency will also contribute $16 million for another, five-year prevention trial in which the anti-amyloid antibody crenezumab will be used to try to prevent Alzheimer’s in young, cognitively healthy members of a large Colombian family.

Members of this family share a rare mutation that triggers Alzheimer’s symptoms in mid-life.  The trial is being run by the Banner Alzheimer’s Institute in Phoenix, Arizona, which is contributing an additional $16 million, by the University of Antioquia in Colombia and by Genentech, which is providing the drug and the balance of funding for the $100 million trial. It will also include a smaller number of US subjects.

What was not discussed today was the $80 million in new Alzheimer’s-research money for 2013 that the administration included in its budget proposal in February. The administration wants the NIH to do the research, but proposed tapping the controversial Public Health Prevention Fund in Sebelius’s office for the money.

That plan is not sitting well with Iowa Democrat Tom Harkin, the chair of the Senate subcommittee that funds the NIH.  As Nature reported in March (see ‘Alzheimer’s funding draws fire at NIH budget hearing‘), Harkin is unhappy at the notion of NIH researchers raiding a fund mandated by the Affordable Care Act to address public-health prevention issues. “I’m a strong supporter of Alzheimer’s research, but this $80 million isn’t happening,” he said.

After today’s announcement, Donald Moulds, the principal deputy assistant secretary in the Office of Planning and Evaluation of the US Department of Health and Human Services, declined to comment directly on Harkin’s remarks.  “We’re very early in the budget conversation for 2013,” he said, adding: “We are absolutely committed to the funding of the $80 million in research in 2013.”



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