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Fiscal Year 2004 Budget

Significant Items In The Senate Appropriation Committee Report

The following section represents FY 2003 Congressional requirements for reports and significant items derived from Senate Report 107-216. These actions discussed below are contingent on inclusion of similar language and funding in the final FY 2003 appropriation and related reports. Additional items may be transmitted at a later date as a result of the final Conference report.

Alzheimer's disease research - The Committee urges the NIA to expand its investment in Alzheimer's disease research, focusing especially on its pathology, the identification of risk factors, more effective treatments, and large-scale clinical trials. In addition, advances in genetics and imaging now make it possible to study Alzheimer's in ways that were never before possible. The Committee encourages the NIA to apply this new knowledge to ongoing longitudinal studies. (Page 126)

Action taken or to be taken

In 1999, at the direction of Congress, the NIA, in conjunction with the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH), and the National Institute of Nursing Research (NINR), embarked on the Alzheimer's Disease Prevention Initiative, which encompasses a number of interrelated efforts including basic, epidemiological, behavioral, and clinical research.

To identify targets for prevention efforts, basic research on Alzheimer's disease (AD) illuminates the mechanisms underlying disease pathology and determines the stages at which intervention might slow progression of dementia, delay onset of symptoms, or eventually prevent the disease. Expanded investment in basic research is identifying potential biomarkers (indicators of biological changes with age) that can aid in diagnosis and in understanding the progression of AD. New findings from basic research are also enabling analyses of disease progress and assessment of treatments in tissue culture and animal models. Epidemiological research on populations suggests genetic and environmental protective and risk factors for the disease and has led to new trials of anti-inflammatory drugs and other agents, such as statins, to treat or prevent AD. Recently funded epidemiological studies also include genetic analyses and neuroimaging components.

Expanding clinical trials, and in particular prevention trials, is another critical objective of the Alzheimer's Disease Prevention Initiative. Until recently, clinical trials have only studied persons who already have clinically detectable mild to moderate AD. While NIA is continuing to evaluate treatments for the cognitive and behavioral symptoms of AD, it is also going beyond treatment to initiate studies on prevention strategies. Under the auspices of the Alzheimer's Disease Prevention Initiative, substances are now being tested on individuals who are at high risk for developing AD in order to prevent or delay the onset of clinical disease.

Early detection of Alzheimer's disease - The Committee also urges the NIA to focus on early detection of Alzheimer's disease so that clinical interventions to slow or stop the progression of the disease may be undertaken. The Committee notes that positron emission tomography (PET) may identify Alzheimer's disease at an early stage and encourages the NIA, in collaboration with the NINDS and the NIMH, to expand its research efforts into early diagnosis of Alzheimer's using PET and other brain imaging methods. (Page 126)

Action taken or to be taken

Neuroimaging studies are continuing to assess whether it is possible to measure aspects of brain function and/or structure that will identify those individuals who are at-risk for AD years before they develop the symptoms of the disease. As possible treatments for AD become more promising, diagnosing the disease at its earliest stages has become increasingly important, and a reliable biological marker of disease progression would also be useful for monitoring treatment response. A number of recently published brain imaging studies have reported results that hold promise for using regional changes on PET and magnetic resonance imaging (MRI) scans as early markers for disease. Progress is being made in understanding the earliest brain changes that occur in the transitions from normal cognition to mild cognitive impairment (MCI) and from MCI to AD, but more research is needed before we know whether and how imaging methods such as MRI and PET can be used most effectively and efficiently in the identification of early presymptomatic changes leading to AD. Therefore, NIA is expanding its focus on early, presymptomatic diagnosis.

The NIA, in conjunction with other NIH Institutes such as NIMH and NINDS, is also developing an Alzheimer's Disease Neuroimaging Initiative. This is being planned as a partnership among the NIA/NIH, academic investigators, the pharmaceutical industry, and the imaging equipment industry, with participation from the Alzheimer's Association and the Institute for the Study of Aging. This proposed longitudinal, multi-site study will include older cognitively normal individuals, people with MCI, and people with early AD. The overall study will be of 5 years duration, and will follow subjects over 3 years to collect serial MRI scans and serial PET scans, clinical and neuropsychological information, and biological fluids and cells for other potential biomarkers. An important aspect of this initiative is that the clinical, imaging, and biological data and samples will be made available to all qualified scientific investigators from both the public and private sectors; there will be no intellectual property claims attached to the data generated from this initiative. Results from this initiative will help to provide information that will allow early identification of those who may benefit from emerging preventative and treatment medications. The data gathered will also help to determine whether neuroimaging outcomes may serve as surrogate endpoints in AD clinical trials, information critically needed to facilitate the development and testing of new drugs for the treatment and prevention of AD.

Cardiovascular aging research - Cardiovascular diseases remain America's leading causes of death of older men and women and a significant cause of disability. The Committee urges the NIA to make cardiovascular research a priority. (Page 127)

Action taken or to be taken

In FY 2002, NIA grantees further characterized a second and distinct type of heart failure (diastolic heart failure) - a progressively debilitating condition common among older people. The new information will help physicians better understand this form of heart failure, and suggests that additional research be undertaken to see if diastolic heart failure is as amenable to treatment as the more well-recognized form of the disease. NIA began support for two basic research projects on adult stem cells and heart disease in FY 2002. NIA is also continuing support for a clinical trial on B-vitamin supplementation and progression of atherosclerosis in healthy older persons. Important research continues on establishing links between high blood pressure, coronary heart disease, and coronary artery bypass surgery with brain changes, including changes in mental capacity. Using state-of-the-art technology, NIA's intramural research program continues to lead the NIH in determining the importance of age-related blood vessel stiffening on the development of cardiovascular disease in minority populations, including novel treatments for blood vessel stiffening. NIA also continues to facilitate the development of promising new investigators in aging research through its annual small grants program and also remains committed to fostering research training and career development of new investigators in the cardiovascular aging field.

Claude D. Pepper Older American Independence Centers - The Committee continues to strongly support these successful centers, which focus on developing innovative and cost effective ways to enhance the independence of older Americans. The centers also play the critical role of developing top level experts in geriatrics. The Committee strongly urges the NIA to make all possible efforts to expand these centers to include a school of nursing. (Page 127)

Action taken or to be taken

NIA continues to value this important program and in FY 2002 has funded two applications that were judged to be of high quality; an additional high quality application will be funded in FY 2003. The most recently reviewed applications were in response to a RFA for Claude D. Pepper Older Americans Independence Centers (OAICs) that was open to applications from schools of nursing along with other institutions. Unfortunately, no applications were received from schools of nursing. At the current time, nursing faculty are actively involved in OAIC research, making important contributions to better our understanding of interventions to improve and maintain health and function among older persons. One of the currently funded OAICs is directed by a nurse with a faculty appointment in the school of nursing at her institution. NIA will continue to welcome applications from schools of nursing for inclusion in the Claude D. Pepper Older American Independence Centers Program.

Demographic and economic research - The Committee commends the NIA for its demography and economic research. It is impressed by the importance of the findings from the Health and Retirement Study and the National Long Term Care Survey regarding the continuing decline in physical and cognitive disability. The Committee urges the NIA to expand funding for these studies and to explore the economic and social impact of the decline for families and society. The Committee also encourages the NIA to assess the role of health as a factor in premature retirement. (Page 127)

Action taken or to be taken

Development, collection, and analysis of longitudinal data on demographics, health, work, retirement, and savings are an NIA priority. NIA supports eleven "Demography and Economics of Aging" centers that are vital sources of information on: trends in population age structures; changes in levels of disease and disability; cost-effectiveness of interventions; decision-making about retirement, pensions and savings; relationship between health and wealth; and health disparities by gender and race. Research areas include: structural retirement analysis, pathways linking education and health, national health accounts, and the relationship between socioeconomic status and health. The Demography Centers will be recompeted this year. The competitive renewal for the National Long Term Care Survey (NLTCS) also is under review.

Older Americans with mental illness - The Committee is concerned about the growing population of older Americans who suffer from mental illness. This is often an underserved population, particularly in rural areas. The Committee encourages the NIA to target funds to study and identify vulnerable older adults who are at risk for such mental illnesses as depression, anxiety, and psychoses. Because advanced practice psychiatric nurses work in a variety of settings, the Committee believes they may be in a unique position to be a critical component of research related to the assessment and treatment of older adults with these disorders. (Page 127)

Action taken or to be taken

NIA and NINR funded a large caregiver clinical intervention, Resources for Enhancing Alzheimer's Caregiver Health (REACH II), to assess a tailored behavioral/cognitive strategy in (a) reducing caregiver depression and burden and (b) increasing caregiver health. New data suggest that HIV+ adults may suffer from subtle cognitive and affective changes. NIA sponsored workshops on "Mental Health Research Issues in HIV and Aging" with NIMH and "Neurobiology of Alcohol and Aging" with the National Institute of Alcohol Abuse and Alcoholism (NIAAA) to reveal gaps in our knowledge and develop research initiatives. Studies of physical exercise interventions suggest that such programs may be useful to abate depression, while loneliness and lack of social contact may respond to sociobehavioral interventions.