Making the Case for a Better Geriatric Model

The majority of older Americans now manage multiple chronic conditions simultaneously, which can present challenges to the geriatricians, clinicians and researchers who are seeking better treatments for aging patients, particularly in the areas of dementia and sarcopenia. While these two examples initially seem distinct, a closer examination of the challenges associated with each reveal more similarities than differences. Leaders in research and geriatrics, including AIM advisor Dr. Bill Evans, are responding, calling for new models to confront these roadblocks that impede effective treatment and stymie innovation in a push for the advanced health care strategies needed for today’s realities.

In their letter [1] recently published in The Lancet, Drs. Timo E Strandberg and Desmond O’Neil of the European Union Geriatric Medicine Society responded to observations laid out in Drs. Brayne’s and Davis’ earlier article [2] regarding the epidemiological difficulties in current research practices around dementia and Alzheimer’s disease onset, prevention and treatment development. Brayne and Davis stressed the need for a clear definition to differentiate dementia in the older population from Alzheimer’s disease, and called for better longitudinal data to establish risk factors and biomarkers for individual patient cohorts, from middle age through death, as each group has different therapeutic needs that currently are not well met. Most importantly, it is critical to reassess clinical trial design models that are utilized to develop and evaluate dementia interventions to be representative of the patient groups who are most likely to need such treatments: namely, the very old and frail.

Stranderg and O’Neil take these ideas further, asserting that dementia research would be vastly more effective if the condition were regarded as

a geriatric syndrome with several causes including neuro-degeneration, disorders of cerebral circulation, and many other factors. This diversity complicates the search for single-mode therapeutic approaches, but opens the door to innovative preventive and therapeutic approaches.

Trials in this area should consider a “geriatric medicine approach…that include[s] individuals of similar age, frailty, or fitness to those who will receive the treatment in practice” and “multi-component interventions” that acknowledges the variance in health status of the population affected by the condition.

Dr. Bill Evans echoed these sentiments in the past, in reference to addressing the burden of sarcopenia and related functional decline in older patients [3]. Like the observations made of the problematic nature of research and clinical trial design practices for dementia, similar obstacles impede the effective “design and implementation of clinical trials with the intent of improving functional status of older people, with the ultimate outcome the approval of a specific drug by the FDA or widespread use of lifestyle interventions to delay or prevent functional declines associated with aging,” Evans said.

Researchers, clinicians and regulatory bodies such as the FDA, Evans wrote, face considerable challenges in developing treatments to “reduce the burden of disease and disability” in an older population that very often is frail or managing multiple diseases. Functional decline is very predictive of other patient outcomes, including institutionalization or death, which makes it an important target for interventions and treatments. However, like dementia, sarcopenia and related functional decline can arise from numerous causes (either the aging process itself, or exacerbated by another chronic condition). Current clinical trial practices that address single diseases make it difficult, if impossible, to take these patient realities into account, thereby greatly increasing the risk of use of new treatments or drugs among the patient population that needs them the most.

These leaders in geriatrics and research put forth two distinct, yet analogous, examples that point to the need for a shift in the way the medical community views the conditions, syndromes and effects of the aging process. The burden of sarcopenia and related disability in the US equates to $18.5 billion [4], and that of dementia totals $200 billion [5]. The costs of the chronic conditions that many older patients simultaneously manage drive health care costs to even higher levels. The aging population is becoming increasingly diverse and complex, and it is imperative that researchers and regulators meet these challenges to assure the health and independence of older Americans – and our nation as a whole.

Citations:
1. Strandberg, TE; O’Neill, D. Dementia—a geriatric syndrome. The Lancet, Volume 381, Issue 9866, pages 533 – 534, 16 February 2013.
2. Brayne, C; Davis, D. Making Alzheimer’s and dementia research fi t for populations. Lancet 2012; 380: pages 1441–43.
3. Evans, WJ. Functional Outcomes for Clinical Trials in Frail Older Persons: Time To Be Moving. J
Gerontol A Biol Sci Med Sci. 2008 February ; 63(2): 160–164.
4. Janssen I, Shepard DS, Katzmarzyk PT, Roubenoff R. The Healthcare Costs of Sarcopenia in the United States. Journal of the American Geriatric Society 52:80–85, 2004.
5. Alzheimer’s Facts and Figures. http://www.alz.org/alzheimers_disease_facts_and_figures.asp. Accessed 21 February 2012.