SYMPOSIA for Research Studies
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The Journal of Prevention of Alzheimer’s Disease - JPAD© Volume 2, Number 4, 2015 APOE genotyping as an additional resource to help with recruitment SYMPOSIA for research studies. Also in 2015, a Researcher Portal will be launched which will allow the Registry to provide additional reporting S1 - PROSPECTIVE READINESS COHORTS, INTERNET- metrics that assess its impact on accelerating enrollment into studies.. BASED REGISTRIES AND MATCHING SERVICES FOR ALZHEIMER’S DISEASE CLINICAL TRIALS. MICHAEL Communications 3: Brain Health Registry, Michael W. Weiner1 ((1) WEINER, JESSICA LANGBAUM University of California San Francisco (UCSF), San Francisco, CA, USA)) The overall goal of this Symposium will be to present updated information concerning the development, use, and progress of based The goal of the internet-based Brain Health Registry registries and matching services to recruit participants and direct them (BrainHealthRegistry.org) is recruitment, assessment, and longitudinal to participate in Alzheimer’s disease clinical treatment trials. There monitoring of subjects for clinical neuroscience studies of all types, will be four presentations from different programs. especially Alzheimer’s disease studies. The Brain Health Registry is not specific for Alzheimer’s disease, but aims to facilitate all types of Communications 1: Alzheimer’s Association TrialMatch. Maria C. neuroscience research. Subjects are recruited to the site by a variety Carrillo1, Keith Fargo1, Beth Kallmyer1 ((1) Alzheimer’s Association of marketing/advertising/public relations methods. Subjects provide National Organization, USA) informed consent (approved by UCSF IRB). Subjects complete an extensive battery of self-report questionnaires and take on line The Alzheimer’s Association’s TrialMatch program is an internet- neuropsychological tests. Subjects who meet specific criteria are based matching service that connects people with clinical studies informed that studies are taking place at clinics in their area, and are on Alzheimer’s disease and other causes of cognitive impairment. provided with contact information to enroll in studies. Thus far, more The program includes a continuously updated database of clinical than 22,000 have joined and 6-month return rate is approximately trials and observational studies from across the entire spectrum of 50%. human-participant studies—including studies for people with disease, their caregivers, and healthy controls of all ages—which includes Communications 4: Cognitive Health in Ageing Register: enrollment criteria and study sites. Currently, the database consists of Investigational, Observational and Trial studies in dementia more than 1,100 study/site combinations. TrialMatch users complete a research – Prospective Readiness cOhort (CHARIOT-PRO). Michael brief profile (more than 100,000 to date) including demographics and T. Ropacki1,2, H. Michael Arrighi1, Robert Perneczky3, Josip Car3, health questions, and the responses are compared to the enrollment Lefkos Middleton3 ((1) Janssen R&D, Fremont, CA, USA; (2) Loma criteria and locations of the studies in the database to provide Linda University School of Medicine, Neurology, Loma Linda, CA, individualized matches, including lay language summaries and contact USA; (3) School of Public Health, Imperial College London, London, information for all matched studies. UK)) Communications 2: Alzheimer’s Prevention Registry. Jessica The CHARIOT-PRO program leverages participants from the B. Langbaum1, Nellie High1, Paul S. Aisen2, Marilyn S. Albert3, CHARIOT Registry at Imperial College London. In the first three Meryl Comer4, Jeffrey L. Cummings5, Jennifer J. Manly6, Ronald years, the CHARIOT Registry enrolled approximately 25,000 C. Petersen7, Reisa A. Sperling8, Gabrielle Strobel9, Michael W. volunteers over the age of 60 without dementia, recruited from the Weiner10, Eric M. Reiman11, Pierre N. Tariot1 ((1) Banner Alzheimer’s surgeries of General Practitioners in the London area. CHARIOT- Institute, Phoenix, AZ, USA; (2) Alzheimer’s Disease Cooperative PRO is a single center prospective readiness cohort study of Study, University of California San Diego, San Diego, CA, USA; approximately 700 participants self-referred or recruited from the (3) Department of Neurology, Johns Hopkins University School of CHARIOT Registry who will be followed for up to 4 years. The Medicine, Baltimore, MD, USA; (4) Geoffrey Beene Foundation goals of CHARIOT-PRO are to better understand the natural history Alzheimer’s Initiative, Washington, DC, USA; (5) Cleveland of cognitive and functional changes in participants at risk for mild Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA; cognitive impairment due to Alzheimer’s disease, as well as to develop (6) Department of Neurology, Columbia University College of a well-characterized, longitudinally followed prospective readiness Physicians and Surgeons, New York, NY, USA; (7) Department cohort for future early Alzheimer’s disease clinical trials. Participants of Neurology, Mayo Clinic, Rochester, MN, USA; (8) Department undergo a series of neuropsychological evaluations to characterize the of Neurology, Harvard Medical School, Boston, MA, USA; (9) patterns of cognitive change and their inter-relationship in the earliest Alzforum, Cambridge, MA, USA; (10) Department of Radiology and stages of cognitive impairment. In addition, how changes relate to the Biomedical Engineering, University of California San Francisco, San clinical presentation of cognitive impairment of the Alzheimer’s type Francisco, CA, USA) will be evaluated over time. An opportunity is possible to identify and characterize individuals with different likelihoods of progressing The Alzheimer’s Prevention Registry (www.endALZnow.org) along different clinical paths, which may form a framework for the was launched in 2012 to provide a shared recruitment resource to evaluation of interventions. In the first nine months of the study, ~ 500 the scientific community in order to facilitate enrollment in participants were enrolled in CHARIOT-PRO. Overall, CHARIOT- Alzheimer’s prevention-related studies and complement and enhance PRO is designed as the largest head-to-head study of clinical outcome local recruitment efforts. To date, more than 113,000 people have assessments collecting real world information regarding prognostic joined, with marketing/advertising/public relations being the primary factors, disease course, functional decline and disease burden on recruitment methods. Enrollees receive regular email communication participants in the earliest stage of disease, that also is developing to keep them apprised of the latest news in Alzheimer’s prevention a well-characterized, longitudinally followed prospective readiness research, as well as email notifications when study opportunities cohort for future early AD clinical trials. become available in their communities. Beginning later in 2015, Registry members will be invited to submit a sample of DNA for 269 S2 - THE LANCET AND THE LANCET NEUROLOGY 86-89. 2. International Monetary Fund World Economic Outlook, SYMPOSIUM ON CLINICAL RESEARCH IN DEMENTIA: April 2015. Where are we headed? Perspectives on potential output. INCREASING VALUE AND REDUCING WASTE. www.imf.org/external/pubs/ft/weo/2015/01/pdf/c3.pdf (accessed April LON S. SCHNEIDER (University of Southern California, USA) 15, 2015); 3. Macleod MR, Michie S, Roberts I, et al. Biomedical research: increasing value, reducing waste. Lancet 2014; 383: 101-4. Communications 1: Towards valuable research design, conduct, and 4. Chalmers I, Bracken MB, Djulbegovic B, et al. How to increase analysis. Malcolm Macleod (Professor of Neurology and Translational value and reduce waste when research priorities are set. Lancet Neuroscience, University of Edinburgh, UK); Communications 2014; 383: 156-65; 5. Ioannidis JPA, Greenland S, Hlatky MA, et al. 2: Tackling waste in the regulation and management of clinical Increasing value and reducing waste in research design, conduct, and trials. Rustam Al-Shahi Salman (Professor of Clinical Neurology, analysis. Lancet 2014; 383: 166-75. 6. Salman RA, Beller E, Kapgan University of Edinburgh, UK); Communications 3: Aims and J, et al. Increasing value and reducing waste in biomedical research priorities of the IMI2 Alzheimer’s Disease Research Platform. regulation and management. Lancet 2014; 383: 176-85. 7. Vaudano E, Elisabetta Vaudano (Principal Scientific Manager & Coordinator, Vannieuwenhuyse B, Van der Geyten S, et al. Boosting translational Innovative Medicines Initiative, Brussels, Belgium) research on Alzheimer’s disease in Europe: The Innovative Medicine Initiative AD research platform. Alzheimer’s & Dementia 2015, DOI: • Panel Discussion: Lon S. Schneider. Panelists: Malcolm Macleod1, http://dx.doi.org/10.1016/j.jalz.2015.02.002 Rustam Al-Shahi Salman1, Elisabetta Vaudano1, Rachel J. Schindler2, Jose Luis Molinuevo3, Sabine Kleinert4, Elena Becker-Barroso2. S3 - UTILITY OF MULTI-MODAL BIOMARKER-ENDPOINT ((1) TBC, Innovative Medicines Initiative; (2) Vice-President, TRIALS IN HIGH-RISK PERSONS TO IDENTIFY Neuroscience Area, Pfizer, New York, NY, USA; (3) Hospital Clinic, CANDIDATE AGENTS FOR AD PREVENTION TRIALS. Barcelona, Spain; (4) Executive Editor, The Lancet, London, UK; MARILYN ALBERT (PhD. Department of Neurology, Johns Hopkins (5) Editor, The Lancet Neurology, London, UK)) University School of Medicine, Baltimore, MD, USA) Prevention and treatment of age-related cognitive impairment Communications 1: Study design