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CTAD: SYMPOSIA, ORAL COMMUNICATIONS, POSTERS
Abstracts
J Prev Alz Dis 2015;2(4):269-396
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OPEN ACCESSCTAD: SYMPOSIA, ORAL COMMUNICATIONS, POSTERS
Abstracts
J Prev Alz Dis 2016;4:262-379
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OPEN ACCESSENDPOINTS 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):128-135
Show summaryHide summaryFor 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.
CITATION:
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
THE ALZHEIMER’S PREVENTION CLINIC AT WEILL CORNELL MEDICAL COLLEGE / NEW YORK - PRESBYTERIAN HOSPITAL: RISK STRATIFICATION AND PERSONALIZED EARLY INTERVENTION
A. Seifan, R. Isaacson
J Prev Alz Dis 2015;2(4):254-266
Show summaryHide summaryIn July 2013, Weill Cornell Medical College founded the first Alzheimer’s Prevention Clinic (APC) in the United States, providing direct clinical care to family members of patients with Alzheimer’s disease (AD) as part of the Weill Cornell Memory Disorders Program. At the APC, patients seeking to lower their AD risk undergo a comprehensive assessment, receive a personalized plan based on rapidly evolving scientific evidence, and are followed over time using validated as well as emerging clinical and research technologies. The APC approach applies the principles of pharmacogenomics, nutrigenomics and clinical precision medicine, to tailor individualized therapies for patients. Longitudinal measures currently assessed in the clinic include anthropometrics, cognition, blood biomarkers (i.e., lipid, inflammatory, metabolic, nutritional) and genetics, as well as validated, self-reported measures that enable patients to track several aspects of health-related quality of life. Patients are educated on the fundamental concepts of AD prevention via an interactive online course hosted on Alzheimer’s Universe (www.AlzU.org), which also contains several activities including validated computer-based cognitive testing. The primary goal of the APC is to employ preventative measures that lower modifiable AD risk, possibly leading to a delay in onset of future symptoms. Our secondary goal is to establish a cohort of at-risk individuals who will be primed to participate in future AD prevention trials as disease-modifying agents emerge for testing at earlier stages of the AD process. The clinical services are intended to lower concern for future disease by giving patients a greater sense of control over their brain health.
CITATION:
A. Seifan ; R. Isaacson (2015): The Alzheimer’s Prevention Clinic at Weill Cornell Medical College / New York - Presbyterian Hospital: Risk Stratification and Personalized Early Intervention. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2015.81
RE-ENGINEERING ALZHEIMER CLINICAL TRIALS: GLOBAL ALZHEIMER’S PLATFORM NETWORK
J. Cummings, P. Aisen, R. Barton, J. Bork, R. Doody, J. Dwyer, J. C. Egan, H. Feldman, D. Lappin, L. Truyen, S. Salloway, R. Sperling, G. Vradenburg, for the GAP-NET Working Groups
J Prev Alz Dis 2016;3(2):114-120
Show summaryHide summaryAlzheimer’s disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer’s Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.
CITATION:
J. Cummings ; P. Aisen ; R. Barton ; J. Bork ; R. Doody ; J. Dwyer ; J. C. Egan ; H. Feldman ; D. Lappin ; L. Truyen ; S. Salloway ; R. Sperling ; G. Vradenburg ; for the GAP-NET Working Groups (2016): Re-Engineering Alzheimer Clinical Trials: Global Alzheimer’s Platform Network. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2016.93