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CTAD: SYMPOSIA, ORAL COMMUNICATIONS, POSTERS
J Prev Alz Dis 2015;2(4):269-396Show summaryHide summary
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ENDPOINTS FOR PRE-DEMENTIA AD TRIALS: A REPORT FROM THE EU/US/CTAD TASK FORCE
B. Vellas, R. Bateman, K. Blennow , G. Frisoni , K. Johnson, R. Katz , J. Langbaum, D. Marson , R. Sperling, A. Wessels, S. Salloway, R. Doody, P. Aisen, Task Force Members
J Prev Alz Dis 2015;2(2):128-135Show summaryHide summary
For Alzheimer’s disease treatment trials that focus on the pre-dementia stage of disease, outcome measures are needed that will enable assessment of disease progression in patients who are clinically normal. The EU/US CTAD Task Force, an international collaboration of investigators from industry, academia, non-profit foundations, and regulatory agencies, met in Philadelphia, Pennsylvania, USA, on November 19, 2014 to discuss existing and novel outcome assessments that may be useful in pre-dementia trials. Composite measures that assess changes in episodic memory, executive function, global cognition, and global function have recently been developed by a number of groups and appear to be sensitive at this stage. Functional measures that involve real-life complex tasks also appear to capture early subtle changes in pre-dementia subjects and have the advantage of representing clinically meaningful change. Patient reported outcomes and novel CSF and imaging biomarkers have also shown promise. More studies are needed to validate all of these tests in the pre-dementia population. Many of them have been incorporated as exploratory measures in ongoing or planned trials.
B. Vellas ; R. Bateman ; K. Blennow ; G. Frisoni ; K. Johnson ; R. Katz ; J. Langbaum ; D. Marson ; R. Sperling ; A. Wessels ; S. Salloway ; R. Doody ; P. Aisen ; and Task Force Members ; (2015): Endpoints for Pre-Dementia AD Trials: A Report from the EU/US/CTAD Task Force. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2015.55
VITAMIN D AND DEMENTIA
T.J. Littlejohns, K. Kos, W.E. Henley, E. Ku?ma, D.J. Llewellyn
J Prev Alz Dis 2016;3(1):43-52Show summaryHide summary
Emerging evidence suggests that low vitamin D concentrations are potentially involved in the pathogenesis of dementia. This is of particular interest when considering the high prevalence of vitamin D deficiency in elderly adults and the urgent need to identify modifiable risk factors for dementia. Studies have found that vitamin D is implicated in procognitive and neuroprotective functions, including the reduction of Alzheimer’s disease hallmarks such as amyloid beta and phosphorylated tau. Cross-sectional studies have consistently found that vitamin D concentrations are significantly lower in individuals with Alzheimer’s disease and cognitive impairment compared to healthy controls. Longitudinal studies support an association between low vitamin D concentrations and an increased risk of dementia and cognitive decline. Neuroimaging studies are beginning to uncover the potential neurodegenerative and cerebrovascular mechanisms that underlie these associations such as white matter hyperintensities and enlarged ventricular volume, although there is currently a lack of longitudinal studies. In contrast to observational studies, findings from interventional studies have produced mixed results on the benefits of vitamin D supplementation on dementia and cognitive outcomes. Interpretation of the findings from these studies is hampered by several major methodological limitations, such as small sample sizes, inadequate doses and inclusion of participants unlikely to benefit from vitamin D supplementation. There is a need for large double-blind randomised-control trials investigating whether vitamin D supplementation can halt or delay the risk of dementia-related outcomes in individuals with low vitamin D concentrations.
T.J. Littlejohns ; K. Kos ; W.E. Henley ; E. Kuźma ; D.J. Llewellyn (2015): Vitamin D and Dementia. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2015.68
BRIDGING THE GAP BETWEEN RESEARCH AND CLINICAL PRACTICE IN ASYMPTOMATIC ALZHEIMER’S DISEASE
A.M. Downing, R. Yaari, D.E. Ball, K.J. Selzler, M.D. Devous, Sr
J Prev Alz Dis 2016;3(1):30-42Show summaryHide summary
Due to the growing global health impact of Alzheimer’s disease (AD), there is a greater need for interventions that prevent or delay the onset of clinical symptoms of this debilitating disease. Clinical trials for disease-modifying compounds in AD have shifted towards earlier stages in the spectrum of illness, including the stage prior to cognitive symptoms. A population of specific interest for clinical research includes individuals with evidence of Alzheimer’s disease pathology who are asymptomatic (ADPa). The challenges and barriers regarding medical treatment of ADPa must be identified and addressed prior to the completion of a positive clinical trial in order to accelerate the translation of research findings to clinical practice. This report applies an existing public health impact model from Spencer and colleagues (2013) to evaluate the readiness of the clinical practice environment to treat ADPa individuals if a disease-modifying agent achieves approval. We contrast the current clinical practice environment with a potential future state through investigating the effectiveness, reach, feasibility, sustainability, and transferability of the practice of treating ADPa individuals.
A.M. Downing ; R. Yaari ; D.E. Ball ; K.J. Selzler ; M.D. Devous, Sr (2015): Bridging the Gap between Research and Clinical Practice in Asymptomatic Alzheimer’s Disease. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2015.86
CLINICAL AND ECONOMIC CHARACTERISTICS OF MILESTONES ALONG THE CONTINUUM OF ALZHEIMER’S DISEASE: TRANSFORMING FUNCTIONAL SCORES INTO LEVELS OF DEPENDENCE
K. Kahle-Wrobleski, J.S. Andrews, M. Belger, S. Gauthier, Y. Stern, D.M. Rentz, D. Galasko
J Prev Alz Dis 2015;2(2):115-120Show summaryHide summary
BACKGROUND: Because Alzheimer’s disease (AD) is characterized by a gradual decline, it can be difficult to identify distinct clinical milestones that signal disease advancement. Adapting a functional scale may be a useful way of staging disease progression that is more informative for healthcare systems.
Objectives: To adapt functional scale scores into discrete levels of dependence as a way of staging disease progression that is more informative to care providers and stakeholders who rely on the functional impact of diseases to determine access to supportive services and interventions.
Design: Analysis of data from the GERAS study.
Setting: GERAS is an 18-month prospective, multicenter, naturalistic, observational cohort study reflecting the routine care of patients with AD in France, Germany, and the United Kingdom.
Participants: Data were from baseline results of 1497 community-living patients, aged ≥55 years, diagnosed with probable AD and their caregivers.
Measurements: We used data from the Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) and mapped items onto established categories of functional dependence, validated using clinical and economic measures. Cognitive function, behavioral symptoms, caregiver burden, and cost were assessed. Based on stages of functional dependence described by the Dependence Scale, individual ADCS-ADL items were used to approximate 6 dependence levels.
Results: There was a significant relationship between assigned level of dependence derived from the ADCS-ADL score and cognitive severity category. As the assigned level of dependence increased, the associated clinical and economic indicators demonstrated a pattern of greater disease severity.
Conclusions: This mapping provides initial support for dependence levels as appropriate interim clinical milestones that characterize the functional deficits associated with AD.
K. Kahle-Wrobleski ; J.S. Andrews ; M. Belger ; S. Gauthier ; Y. Stern ; D.M. Rentz ; D. Galasko (2015): Clinical and Economic Characteristics of Milestones along the Continuum of Alzheimer’s Disease: Transforming Functional Scores into Levels of Dependence. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2015.53