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A special budget for Alzheimer's and related dementias

Dr. Richard Hodes
Richard HODES,
Director,
Office of the Director (OD)
.

Just last week, I had the honor of presenting, on behalf of NIH Director Dr. Francis Collins, the first-ever NIH Professional Judgment Budget for Alzheimer’s disease and related dementias. Outlined at the July 27 meeting of the HHS Secretary’s Advisory Council on Alzheimer’s Research, Care, and Services, the proposal—commonly referred to as a Bypass Budget—lays out NIH’s plan to speed discovery into these devastating disorders, aimed at meeting the research goal of the National Plan to Address Alzheimer’s Disease—to prevent and effectively treat Alzheimer’s disease by 2025.

We estimate that an additional $323 million would be needed, above an assumed baseline appropriation for fiscal year 2017, as an increased investment for meeting the national research goal.

Where would the money go?

These funds would be applied across the research spectrum, from basic science to translational to clinical research. Examples include but are not limited to:

  • Discovery and validation of novel targets for therapy development based on gene, protein, and metabolic networks;
  • Integrating studies of the fundamental biology/neurobiology of aging with Alzheimer’s research;
  • Adding molecular phenotyping and genotyping to longitudinal cohort studies, especially in those individuals at highest risk of disease;
  • Phase I, II, and III drug and nonpharmacological clinical trials in presymptomatic, cognitively impaired, and symptomatic individuals, including those with neuropsychiatric symptoms;
  • Development of novel imaging and biofluid biomarkers for early diagnosis and clinical trial outcomes;
  • Research to design and test clinical interventions and models of care for people with dementia and their caregivers.

Congress wants to hear from us directly

In legislation last year, NIH was ordered by the Congress to prepare this Bypass Budget. It is only the third time NIH has been asked to report directly on opportunities and funding needs in an area the Congress deems of highest priority, now joining cancer and HIV/AIDS in development of a Professional Judgment Budget to accelerate discovery. We will be issuing this budget annually through FY2025, updating what it will take to bring disease-modifying treatments to Alzheimer’s patients as soon as possible.

The estimate is called a “bypass” budget because it is transmitted directly to the Congress without change, but with opportunity for comment by the NAPA Council and the Secretary of Health and Human Services. The Bypass Budget will be sent by the President to the Congress, as requested.

Research community helped develop milestones

Based on an important balance of investigator-initiated research grants and NIH initiatives, this Bypass Budget was constructed from scientific milestones that NIH staff developed with input from the larger scientific community. Led by NIA’s Division of Neuroscience, several NIH Institutes and Centers contributed, in particular the National Institute of Neurological Disorders and Stroke, which has the second largest portfolio in Alzheimer’s disease and a focus on Alzheimer’s-related dementias.

The budget was primarily informed by recommendations developed after consultation with the larger research community during international conferences NIH hosted over the past several years: the recent Alzheimer’s disease summits in May 2012 and February 2015, and conferences on related dementias (May 2013) and Down syndrome (April 2013).

Together, we can accelerate progress

Now that this first Professional Judgment Budget for Alzheimer’s is on the table, I look forward to working with Congress and the research community to discuss possibilities for stepped-up research in FY2017, the year of the first Bypass Budget estimate. If NIH can expand and build upon our base of scientific knowledge, we believe we can identify and implement the treatment and prevention strategies for combating Alzheimer’s disease that are so desperately needed.

I invite you to read through the Bypass Budget and research plan and consider how you may join us in reaching for a cure for Alzheimer’s disease and related dementias.