Nonmelanoma skin cancer is associated with reduced Alzheimer disease risk

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Allergan, Merck, Neuralieve, Pfizer

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American Headache Society, Cognimed, Diamond Headache Clinic Research, Market Force Communications, Merck, Migraine Research Foundation, Scienta, Talley Management

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Oxfor University Press; Baxter Publishing

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Allergan, Autonomic Technologies, MAP Pharma, Neuralieve, Novartis, NuPathe

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Title: The Migraine Preventive Questionnaire Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: Ortho McNeil February 2006 - present Title: Migraine Interictal Burden Scale Development Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D., Sponsor: Ortho McNeil June 2006 – present Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Tolerability of TREXIMA (Sumatriptan Succinate/ Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed with Probable Migraine without Aura Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: GlaxoSmith Kline August 2006 – present Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Response to a Single Treatment with Oral MK-0974 with Placebo and Comparator in Subjects with Moderate to Severe Acute Migraine with or without Aura Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: Merck October 2006 – present Title: Long-Term Intermittent Treatment of Acute Migraine with MK-0974 300 mg Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: Merck October 2006 – present Title: Improving the Measurement of Allodynia Principal Investigator: Richard B. Lipton, MD; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: Merck May 2008 – present Title: Proposal to Assess Cardiovascular Profile in Migraine Principal Investigator: Richard B. Lipton, M.D. Sponsor: Merck July 2008 - present COMPLETED – PHARMA/FOUNDATION I have participated in at least 50 industry-sponsored clinical trials as PI or co-PI. Some recently completed are: Title: A Randomized, Double-Blind, Multi-Center, Placebo- Controlled Cross-Over Study to Determine the Consistency of Response for Trexima (Sumatriptan Succinate/Naproxen Sodium) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: GlaxoSmith Kline October 2005 – June 2006 Title: A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Co- Administered with Acetaminophen for the Treatment of Acute Migraine Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: Merck February 2006 – October 2006 Title: A Multi-Center, Prospective, Randomized, Double- Blind Parallel Group, Single Dose, Placebo Controlled Study of the Efficacy and Safety of 50 mg Diclofenac Potassium (K) Powder Sachet Compared to Placebo Powder Sachet in Subjects with Acute Migraine Attacks Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: ProEthic Pharmaceutical, Inc. April 2006 – January 2007 Title: Precision Implantable Stimulator for Migraine (PRISM) Occipital Nerve Stimulation (ONS) for Migraine Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: Advanced Bionics March 2006 – March 2007

NIA 5PO1 AG003949 (PI: R. Lipton) 9/1/04-6/30/10 Einstein Aging Study The overall focus of the Einstein Aging Study (EAS) is to identify the earliest cognitive, metabolic, anatomic, and neuropathologic markers that distinguish normal aging from dementia in a large community-based sample. NIA PO1-AG03949 9/1/04-6/30/10 Einstein Aging Study: Project 1: Risk Factors and Stages of Cognitive Decline Project Leader: R. Lipton NIA RO1 AG25119-01 (PI: J. Verghese) 7/1/05-6/30/10 Latent Mobility Abnormalities and Frailty This project will provide new and vital information about the cognitive and physical attributes of early frailty, their biological basis, and identify opportunities to introduce specific interventions very early in at-risk older adults to ameliorate disability and maintain functional independence. Role: Investigator NIA 5 PO1 AG027734 (PI: N. Barzilai) 8/1/07-7/31/12 Role of Genes in Exceptional Longevity In Humans Project 4: Longevity, genotypes, phenotypes and cognition Project Leader: R. Lipton This project assesses the contribution of longevity genes to successful cognitive aging and risk of dementia in a sample of older Ashkenazi Jews. K23NS051409 (PI: B. Friedman) 04/1/06-03/31/11 Optimizing the Emergency Department Diagnosis and Treatment of Migraines Role: Primary Mentor K23AG030857 (PI: R. Holtzer) 08/07-07/12 NIA - Beeson Career Award in Aging Predictors of gait and falls in aging: Linking cognitive control to genes Role: Co-Mentor 1KL2RR025749 (PI: A. Sanders) 07/01/09-06/30/13 Clinical and Translational Science Award (CTSA) Research Career Development Award Role: Primary Mentor KL2 (PI: J. Steinerman) 07/01/10-06/30/11 Career Development Award Einstein-Montefiore Institute for Clinical and Translational Research Community Powered Brain Health Research Role: Primary Mentor NIA 5PO1 AG003949 Einstein Aging Study (PI: R. Lipton) NIA PO1-AG03949 3/1/07-5/1/09 Einstein Aging Study (Supplement): Genetics of Cognitive Decline (PI: R. Lipton) K23NS47256-01 (PI: R. Saunders-Pullman) 7/01/04- 06/30/09 Mentored Clinical Research Award Role: Primary Mentor K23AG024848 (PI: J. Verghese) 07/1/2004- 06/30/07 Mobility and cognitive aging Paul B. Beeson Career Development Award in Aging Role: Primary Mentor

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Title: Familial Risk of Transformed Migraine Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: National Headache Foundation October 2005 - present Title: Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere Device- ESCAPE Study Principal Investigator: Richard B. Lipton, M.D.; Co- Principal Investigator: Brian M. Grosberg, M.D. Sponsor: St. Jude Medical December 2005 – present Title: Towards a Migraine Gene Population Lab Principal Investigator: Richard B. Lipton, M.D. Sponsor: Migraine Research Foundation January 2008 - present Title: American Migraine Prevalence and Prevention Study (AMPP) Principal Investigator: Richard B. Lipton, M.D. Sponsor: National Headache Foundation January 2010 - present

Minster Pharma

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Data Safety Monitoring Board for “Exercise, Aging, and Cognition: Effects and Mechanisms”, funded by National Institute of Aging R01 AG033546, PI: Yaakov Stern, Columbia University.

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I have received honoraria for serving as a reviewer for the following peer review panels: Member National Cancer Institute Special Emphasis Panels for review of Clinical Studies Program Project Applications, February 2007, June 2007. Member Epidemiology Peer Review Panel for the 2007 Breast Cancer Research Program (BCRP), Congressionally Directed Medical Research Programs (CDMRP), U.S. Army, Department of Defense, August 2007. 2008 Member National Institute of Aging Special Emphasis Panels for review of Program Project Applications, July 2008, August 2008.

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For How Long is WTC Exposure Associated with Incident Airway Obstruction PI: Charles B. Hall. National Institute of Occupational Safety and Health, award 1U01-OH10412-01. 9/1/2012-8/31/2014, 33% LOE. The study uses innovative statistical methods – parametric survival models with change points – to study the incidence of new onset obstructive airway disease (OAD) diagnoses and symptoms over the first ten years following WTC exposure, with the goal of determining the length of time that exposure response gradients are observed among exposed FDNY firefighters. This study will allow estimation of the length of time that a relatively short-term, high intensity exposure may be associated with incident respiratory illness. Bronchial reactivity and the course of lung function after WTC exposure. PI: Thomas K. Aldrich. National Institute of Occupational Safety and Health, 1U01OH010411-01, 9/1/2012- 8/31/2014, 10% LOE. This study will aim to (1) to quantify the change in bronchial reactivity over 10 years; (2) to determine whether initial and/or subsequent bronchial reactivity is associated with the decline in lung function from 2002 to 2013; and (3) to determine whether anti- inflammatory treatment (mainly inhaled corticosteroids [ICS]) ameliorates bronchial hyperreactivity and/or lung function decline in approximately 350 firefighters exposed to the rescue/recovery effort at the World Trade Center after the 9/11/2001 terrorist attack. Dr. Hall is the lead biostatistician for the study. Data Coordinating Center for Medical Monitoring of NYC Firefighters and EMS Personnel Exposed to the World Trade Center Collapse of September 11, 2001. PI: David Prezant. National Institute of Occupational Safety and Health. Contract # 200-2011-39378. 7/1/2011-present, 10% LOE. This grant supports the medical monitoring of New York City Fire Department Personnel exposed to the collapse of the World Trade Center as well as research related to the continued health of that cohort. Dr. Hall is the lead statistician. Cohort Studies of Incident Cancer in the FDNY Responder Population. PI: David Prezant. National Institute of Occupational Safety and Health. 7/1/2011-present, 10% LOE. Contract # 200-2011-39489. The main objective of this three-year research project is to analyze the cohorts of FDNY firefighters and EMS workers, both WTC-exposed and non-WTC exposed in order to compare cancer incidence by WTC-exposure status during the early post-9/11 years. To achieve this objective, we intend to conduct longitudinal surveillance of cancer diagnoses in WTC-exposed and non- WTC-exposed individuals through 2008 and later, as data become available. We have already completed analyses in an FDNY firefighter cohort on cancer incidence rates 7 years post-9/11. We will continue to add follow-up observational years to the firefighter cohort, conduct similar analyses in FDNY EMS workers and then compare the cancer burden between these two cohorts. These populations are treated as two distinct groups of workers because of previously described demographic and exposure differences. Dr. Hall is the lead statistician for the study. Statistical Core, The Einstein Aging Study PI: Charles B. Hall (PD: Richard B. Lipton). National Institute of Aging, Grant # P01 AG03949, 4/1/2011-3/31/2016. 17% LOE. The Statistical Core is responsible for the quality of data management and analysis for all cores and projects of this program project that includes several observational cohort studies. The Statistical Core works to identify cross project analyses of scientific significance, to develop new statistical methodology appropriate to address Aging Study scientific questions, to develop robust cognitive test norms, and to identify and distinguish factors that predict age-related cognitive decline from those that predict dementia-related cognitive decline. Dr. Hall was Leader of the Core from 2001-2012, and remains a statistician for the study. Two Preclinical Latent Scores to Predict Occurrence of DAT. PI: Chengjie Xiong, Washington University. AECOM PI: Richard Lipton. National Institute of Aging, Grant # R01 AG034119, 8/1/2010-7/31/2015. 5% LOE. The cognitive decline associated with Alzheimer's disease (AD) occurs years prior to the clinical diagnosis. However, the emergence of the earliest cognitive and functional impairment and the precise duration of the preclinical progression remain poorly understood by clinicians. Better methods are therefore urgently needed to reliably detect the antecedent cognitive and functional changes before the onset of the dementia of Alzheimer type (DAT). This interdisciplinary team of investigators at the Washington University, Rush Univeristy, and the Albert Einstein College of Medicine will develop such methods to improve detection of the preclinical longitudinal cognitive and functional changes of AD using the state-of-the-art longitudinal statistical methods, modern psychometric theory (i.e., IRT), and cutting-edge bioinformatics techniques. Dr. Hall is a statistician on the study. Clinical and Translational Science Award. PI: Harry Shamoon. NIH National Center for Research Resources. Grant #1-UL1-RR025750-01. 5% LOE. 5/19/2008-4/30/2013. Dr. Hall is part of the Biostatistics/Epidemiology/Research Design Core, providing support in these areas to investigators. Albert Einstein Cancer Center. PI: David Goldman. National Cancer Institute, Grant #P30 CA13330-35. 5% LOE. 7/1/07- 6/30/13. Support to biostatistics shared resource for cancer center. Dr. Hall is one of the statisticians supporting the shared resource. Intensive Blood Pressure Reduction to Lessen Functional Decline. PI: Leslie Wolfson (University of Connecticut School of Medicine). National Institute of Aging, Grant # 2R01AG022092-06A1. 8/15/2011-7/31/2016. 3% LOE. Ambulatory blood pressure has been shown that in persons whose initial and 2-year 24-h systolic BP was <130 mmHg, significantly lower white matter hyperintensity volume and better mobility was noted (faster gait velocity, decreased turn and stair descent time) than those whose 24-h systolic BP was >140 mmHg. The goal of this randomized intervention study is to assess causality between 24-h systolic BP and reductions in mobility, associated with WMH in older people. The study will determine the impact of reducing the 24-h systolic BP to a goal of <125 mmHg (intensive BP control) vs. a goal of <140 mmHg (standard BP control). Dr. Hall is the lead statistician for the study. Screening and Diagnosis of Mild Alzheimer's Disease in Latino Elders PI: Ellen Grober. National Institute of Aging, Grant # 1R21AG036935-01A1. 5% LOE. 9/1/2011- 8/31/2013. Recognition of mild dementia is poor in primary care settings where most Latino/Hispanic elders receive their care. Prompted by the lack of accurate and efficient case finding methods to identify mild dementia in disparity groups, we have developed and validated an efficient and cost-effective tool to identify patients with early dementia and AD in primary care settings. In this R21, we extend our case-finding efforts to Spanish speaking patients from a federally qualified community health center that serves a largely Latino/Hispanic community in the South Bronx. Screen positive patients and a random sample of screen negative controls will undergo a research quality evaluation to determine dementia status. This will be the standard against which the accuracy of our case finding tool will be assessed. We will compare the operating characteristics of our case finding tool with the most widely used dementia screening test and determine the most accurate and efficient way to identify cases of mild dementia in Latino/Hispanic elders. Diagnostic information and treatment recommendations will be provided to the patient's physician. In this study Dr. Hall provides overall direction to statistical analyses and management of the data collected in the study, in particular quality control and analyses of the possible effect of study attrition on the estimation of the primary outcome. Role of Genes in Exceptional Longevity in Humans PI: Nir Barzalai. National Institute of Aging, Grant # P01 AG027734. 04/01/2007-03/31/2012. 11% LOE. The objective of this study is to identify genes that contribute to exceptional longevity in humans. Dr. Hall provided statistical analyses to the confirmatory prospective studies of candidate genes. Data Coordinating Center for Medical Monitoring of NYC Firefighters and EMS Personnel Exposed to the World Trade Center Collapse of September 11, 2001. PI: David Prezant. National Institute of Occupational Safety and Health, Grant # 5-U1O-OH008242, 7/1/2004-6/31/2011, 40% LOE. This grant supports the medical monitoring of New York City Fire Department Personnel exposed to the collapse of the World Trade Center as well as research related to the continued health of that cohort. Dr. Hall was the lead statistician for the research. Gene Expression & Proteomic Profilling of Benign Breast Tissue & Risk of Breast Cancer. PI: Tom Rohan. Breast Cancer Research Foundation. 10/1/2008 - 9/30/2009. 1.25% LOE. This study will evaluate methods for the proteomic profiling of formalin-fixed breast tissue. Dr. Hall was the statistician for the study. Changes in Cognitive Performance in Preclinical AD: A Collaborative Analysis. PI: Brent Small (University of South Florida). AECOM PI: Richard Lipton. National Alzheimer's Coordinating Center Project #2008-01 through University of South Florida. 7/1/2008 - 6/30/2009. 2% LOE. The goal of this project is to better understand trajectories of change in the period prior to the diagnosis of AD by combining data from 5 longitudinal studies of aging and dementia. Dr. Hall was a statistical consultant. Proteomic Prediction of Breast Cancer Risk: A Cohort Study. PI: Tom Rohan. United States Department of Defense, Grant #BC043301. 3/1/2005-2/28/2009. 7.7% LOE. This case control study will attempt to identify proteomics markers associated with the development of breast cancer. Dr. Hall was the primary statistician for the study. Culture-Fair Dementia Screening. PI: Ellen Grober. National Institute of Aging, Grant # R01 AG017854, 10/1/2002-9/30/2007. 15% LOE. This project addresses the urgent public health need for a dementia screening program in primary care settings (e.g., HMO's, managed care, group practices) where racial/ethnic minorities, the fastest growing segment of the older United States population, receive their medical care. Dr. Hall was the statistician on the study. Albert Einstein Cancer Center. PI: David Goldman. National Cancer Institute, Grant #CA13330-33.7/1/04-6/30/07. 5% LOE. Support to biostatistics shared resource for cancer center. Dr. Hall was one of the statisticians supporting the shared resource.

Consultant to University of Connecticut Health Center for “The Provider and Organization in Asthma Guidelines”, a clinical trial of interventions to improve clinician performance in their management of pediatric asthma funded by National Heart, Lung, and Blood Institute (grant 5R01HL070785-05, PI: Michelle M. Cloutier, MD). Consultant to University of Connecticut Health Center for “Brain Changes Underlying Impaired Mobility”, a prospective study to examine the association of changes in white matter signal abnormalities on structural magnetic resonance imaging with changes in mobility, cognition, blood pressure, and other health outcomes, funded by National Institute of Aging (grant 5R01AG022092-05, PI: Leslie Wolfson, MD). 2007-present Chair of Data Safety Monitoring Committee, “Arg/Arg/ Genotype and Long Acting Beta Agonists in Asthma”, IRB #AAAC1135, Columbia University College of Physicians and Surgeons. Culture-Fair Dementia Screening. PI: Ellen Grober. National Institute of Aging, Grant # R01 AG017854, 10/1/2002-9/30/2007. 15% LOE. This project addresses the urgent public health need for a dementia screening program in primary care settings (e.g., HMO's, managed care, group practices) where racial/ethnic minorities, the fastest growing segment of the older United States population, receive their medical care. Dr. Hall is the statistician on the study. Albert Einstein Cancer Center. PI: David Goldman. National Cancer Institute, Grant #CA13330-33.7/1/04-6/30/07. 5% LOE. Support to biostatistics shared resource for cancer center. Dr. Hall is one of the statisticians supporting the shared resource. Competitive renewal was recently awarded

Gene Expression & Proteomic Profilling of Benign Breast Tissue & Risk of Breast Cancer. PI: Tom Rohan. Breast Cancer Research Foundation. 10/1/2008 - 9/30/2009. 1.25% LOE. This study will evaluate methods for the proteomic profiling of formalin-fixed breast tissue. Dr. Hall is the statistician for the study. Spiritual vs. Educational Intervention on QOL in Low-Income Cancer Patients. 7/1/03-6/30/07. American Cancer Society. PI: Alyson Moadel. 10% LOE. This study will compare the effects of a psych-educational vs. psycho-spiritual intervention on quality of life and medical outcome of underserved, late-stage cancer patients. Dr. Hall is the statistician for the study.

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(1) CRI Lifetree, Medical Director, Neurology

(1) ProGevity Neuroscience, (2) Click Therapeutics

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(1) Einstein-Montefiore Institute for Clinical and Translational Research, supported by NIH grants KL2RR025749, UL1RR025750, Principal Investigator, 2010-2011 (2) NIH Clinical Research Loan Repayment Program, 2010-2011

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