Clinical Trials 101: Resources for Alzheimer’s Patient

  • Clinical

    Trials/Questions

    National Institutes of Health (NIH)

    Understanding Clinical Trials – Answers the frequently asked questions about clinical trials, who can participate, benefits and risks, types of clinical trials and phases and explains key terms.
    http://clinicaltrials.gov/ct2/info/understand

    NIH & Clinical Research

    Clinical Research because lives depend on it - Explains how clinical research works, who can participate, how to learn more, and where to find clinical trials.
    http://clinicalresearch.nih.gov/how.html

    National Institute of Aging (NIA) and Alzheimer’s Disease Education And Referral Center (ADEAR)

    Participating in Alzheimer’s Disease Clinical Trials and Studies Fact Sheet – Describes Alzheimer’s disease clinical studies and steps in the process.
    http://www.nia.nih.gov/alzheimers/publication/participating-alzheimers-disease-clinical-trials-and-studies-fact-sheet

    Clinical Trials and Older People - Describes what clinical trials are and why you might want to participate, benefits and risks and questions to ask. 
    http://www.nia.nih.gov/health/publication/clinical-trials-and-older-people

    Alzheimer’s Disease: Unraveling the Mystery - Part 3 of this document covers the different types and phases of clinical trials, how to learn more about research opportunities and questions to consider before participating.
    http://www.nia.nih.gov/alzheimers/publication/alzheimers-disease-unraveling-mystery

    National Institute of Mental Health

    A Participant’s Guide to Mental Clinical Research - Explores information about volunteering in clinical trials. It provides an excellent overview and is not specific to mental health.
    http://www.nimh.nih.gov/health/publications/a-participants-guide-to-mental-health-clinical-research/index.shtml

    National Library of Medicine (NLM) and NIH

    MedlinePlus – This database searches authoritative information from NLM, NIH, other government agencies and health-related organizations to help answer health questions. 
    http://www.nlm.nih.gov/medlineplus/clinicaltrials.html

    Food and Drug Administration

    Participating in Clinical Trials - Clinical trials are voluntary research studies, conducted in people, that are designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
    http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/default.htm

    Clinical Trials of Medical Treatments: Why Volunteer? – Describes clinical trials, reasons to participate, questions to ask and where to get more information.
    http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/ucm129557.htm

    Project IMPACT (Increase Minority Participation and Awareness of Clinical Trials)

    Patients/Consumers’ Information on Clinical Trials – Information from the National Medical Association to promote greater participation of African Americans in clinical trials. Discusses types of clinical trials, informed consent, questions to ask, and why participation by minorities is important.
    http://www.impact.nmanet.org/patientsconsumers

    The Center for Information & Study on Clinical Research Participation (CISCRP)

    Becoming Educated About Clinical Trials – Clear, easy-to-understand information about the clinical researchprocess and its importance to public health. Sections include: Questions to Ask, Frequently Asked Questions, Facts & Figures, Informational Videos, Patient Perspectives, etc.
    http://www.ciscrp.org/patient/index.html

    *Education Before Participation – A more concise version about the nature of clinical trials, questions to ask, participant rights, and benefits and risks.
    http://www.ciscrp.org/patient/educ_materials/brochures/Brochure_English_web.pdf

    *African Americans and Clinical Research - Explains clinical research, the importance of having African Americans participate, volunteer safeguards, and questions to ask.
    http://www.ciscrp.org/patient/educ_materials/brochures/ciscrp_AA_brochure_web.pdf

    Alzheimer’s Association

    Clinical Studies - The Alzheimer’s Association is a voluntary health organization in Alzheimer’s care, support and research. The Clinical Studies section of their webpage describes reasons to consider participating in a clinical trial, the various phases of clinical trials, informed consent, and how to find a study.
    http://www.alz.org/alzheimers_disease_clinical_studies.asp

    CenterWatch

    Overview of Clinical Trials - CenterWatch, a Boston-based publisher of medical information, provides an overview of clinical trials and more detailed explanation of the various phases of human clinical trials.
    http://www.centerwatch.com/clinical-trials/overview.aspx

    Society for Women’s Health Research

    Inclusion of Women in Medical Research - Explores the importance of having women involved in research clinical studies.
    http://www.womenshealthresearch.org/site/PageServer?pagename=hs_learn

    U.S. Department of Health and Human Services, Office of Human Research Protections

    *Becoming a Research Volunteer : It's Your Decision (PDF) – This 2-page brochure reviews information about clinical trials, why research is important, points to remember and questions to ask about the research volunteer process.
    http://www.hhs.gov/ohrp/education/brochures/3panelfinal.pdf

  • Alzheimer’s

    Clinical Trials

    Possible search terms: Alzheimer’s disease, Dementia, Memory loss

    NIH ClinicalTrials.gov – ClinicalTrials.gov is a registry of federally and privately supported clinical trials and provides information about a trial's purpose, participation, locations, and contacts.
    http://clinicaltrials.gov

    Alzheimer’s Association – Use the Clinical Trials Index to search specifically for Alzheimer’s disease and related disorders research studies. Search by a U.S. state or Canadian province.
    http://www.alz.org/alzheimers_disease_clinical_trials_index.asp

    National Institute of Aging and Alzheimer’s Disease Education And Referral Center (ADEAR) – Provides the ability to search by trials by location (city, state, zip code), condition and disease stage, or by specific treatment (drug, device, procedure, etc.)
    http://www.alzheimers.org/clinicaltrials/search.asp

    Center for Information & Study on Clinical Research Participation (CISCRP)-Search Clinical Trials – Search for clinical trials by entering search terms or checking a specific disease or condition. Search can be limited by zip code or U.S. state or Canadian Province.
    http://www.searchclinicaltrials.org/fastsearch/searchform.asp

    NIH Clinical Center – Search the clinical trials taking place at the NIH Clinical Center in Bethesda, Maryland.
    http://clinicalstudies.info.nih.gov/

    Alzheimer Research Forum – Drugs in Clinical Trials – This site searches only clinical drug trials. Provides several choices for sorting and viewing results. 
    http://www.alzforum.org/dis/tre/drc/default.asp

    CenterWatch – CenterWatch is a Boston-based publisher of medical information; a subsidiary of Jobson Medical Information, LLC. All trials listed have approval of the researcher’s Investigative Review Board. Search by medical condition or therapeutic area (medical specialty) 
    http://www.centerwatch.com/clinical-trials/

  • Additional

    Resources

    Books

    The Alzheimer's Project: Momentum in Science (2009, ISBN 978-1586487560) by John Hoffman, Susan Froemke with Susan Golant; Foreword by Maria Shriver. Based on the HBO Documentary Film. Takes a look at the research devoted to untangling the science of Alzheimer’s disease including the development of new drugs. Also available as a DVD.

    The Alzheimer's Action Plan: The Experts' Guide to the Best Diagnosis and Treatment for Memory Problems (2008, ISBN 0312355394) by P. Murali Doraiswamy M.D., Lisa P. Gwyther M.S.W., and Tina Adler. A highly recommended and clearly written book on early Alzheimer’s disease, testing and diagnosis, treatments, clinical trials, coping and living with the disease.

    The 10 Best Questions for Living with Alzheimer’s (2008, ISBN 978-1416560517) by Dede Bonner and Roger A Brumback. A logical, sequential look at the progression of the disease with questions and answers to assist you through the process. Looks at assembling a medical team, choosing treatments including clinical trials, safety, day care and residential care, support for the caregiver and legal and financial issues. It’s a book you’ll refer back to many times.

    The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial(2007,ISBN 978-0615156644) by Ken Getz. This book looks at why clinical research studies are so important in the advancement of medical science and covers information the potential volunteer should know and ask to determine whether to participate. Includes information on insurance coverage, compensation and tax ramifications. For more information: http://www.ciscrp.org/patient/educ_materials/books_gift.html

    Alzheimer's Early Stages: First Steps for Family, Friends and Caregivers (2003, ISBN 978-0897933971) by Daniel Kuhn. A balanced approach to diagnosis, symptoms, risk factors, awareness, changing roles, decision-making, communication, future planning, staying healthy, caregiver care, and resources. A short segment discusses the participation in clinical trials. Also available as an audio CD.

    Alzheimer's for Dummies (2003, ISBN 978-0764538995) by Patricia B. Smith, Mary M. Kenan, Psy.D. Written in the easy-to-understand language that this series is known for by someone who is both a medical writer and has been an Alzheimer’s caregiver. Takes the reader through the journey from diagnosis, symptoms and treatment evaluation, including a full chapter on clinical trial participation, through managing the illness, and making medical, financial and legal decisions.

    Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials(2002, ISBN 978-1930624092) by Ken Getz and Deborah Borfitz. A guide about participating in clinical trials, what you need to know beforehand, understanding informed consent, and safety measures.

    Making Informed Medical Decisions: Where to Look and How to Use What You Find (2000, ISBN 1565924592) by Nancy Oster, Lucy Thomas, and Darol Joseff. A guide to understanding the medical research process, informed consent and making medical decisions.

    DVDs

    The Alzheimer's Project (2009) (Online and DVD)
    4-part series; 30-120 minutes each
    An Emmy Award winning series that looks at Alzheimer’s disease, families touched by the disease, new discoveries, and clinical research. The series includes: The Memory Loss Tapes, Grandpa, Do You Know Who I Am? with Maria Shriver, Momentum in Science, Caregivers
    http://www.hbo.com/alzheimers/
    *Guide (PDF): http://www.hbo.com/alzheimers/downloads/Science.com.pdf

    Entering a Clinical Trial: Is It Right For You?(Drug Clinical Trials) (2004)(Online and DVD) 
    Dana Farber Cancer Center, 21 minutes. 
    Medical professionals and patients discuss clinical drug trial participation. While centered on cancer drug clinical trials, the information presented is useful for anyone considering participating in a clinical trial. 
    http://www.dana-farber.org/res/clinical/trials-info/default.html

    YouTube videos – NIH4Health (viewed December 15, 2009) – While centered on cancer clinical trials, the information is pertinent to clinical trials for other conditions. Videos are captioned as well as spoken. 

    Cancer Clinical Trials: What is a Clinical Trial? 2:59 min.
    http://www.youtube.com/watch?v=ZxwKggJ2ACs&;feature=channel

    Newsletters

    National Institute on Aging & the Alzheimer's Disease Education and Referral (ADEAR) Center - Various publications, reports and Fact Sheets on Alzheimer's Disease and Caregivers.  Some publications include information on clinical trials under their "testing therapies" section.
     http://www.nia.nih.gov/alzheimers/publication/2011-2012-alzheimers-disease-progress-report

    Medical Heroes (CISCRP) – Features stories of individuals who volunteered for various types of clinical trials (not specifically Alzheimer’s disease), and other information about clinical trials.
     http://www.ciscrp.org/patient/medheroes_newsletter.html

    MedlinePlus Magazine – a publication of the National Institutes of Health and the Friends of the National Library of Medicine.
    Summer 2008, 3(3):2-3 The Value of Medical Research
    Summer 2008, 3(3):4-5 Clinical Trials: Key to Medical Progress
     http://www.nlm.nih.gov/medlineplus/magazine/issues/summer08/toc.html
    Fall 2010, 5(3):4-5 Clinical Trials  
    Fall 2010, 5(3):4-5 Alzheimer's disease 
    http://www.nlm.nih.gov/medlineplus/magazine/issues/fall10/toc.html
    Summer 2011 6(2):2-3 The Importance of Clinical Trials
    http://www.nlm.nih.gov/medlineplus/magazine/issues/summer11/toc.html
    Summer 2013 8(2):2-3 Unlocking the Brain
    Summer 2013 8(2): 16-17 Understanding Memory Loss
    http://www.nlm.nih.gov/medlineplus/magazine/issues/summer13/toc.html

  • Español

    Spanish

    Asociación de Alzheimer (Alzheimer’s Association)

     http://www.alz.org/espanol/overview-espanol.asp

    Biblioteca Nacional de Medicina and Institutos Nacionales de la Salud – (National Library of Medicine and the Institutes of Health)

    MedlinePlus – MedlinePlus ha recopilado la información más confiable proveniente de fuentes autorizadas tales como la Biblioteca Nacional de Medicina y los Institutos Nacionales de la Salud, así como otras agencias gubernamentales y organizaciones de servicios para la salud.
    http://www.nlm.nih.gov/medlineplus/spanish/alzheimersdisease.html

    Tutorial sobre ensayos clinicos - (Clinical trial tutorial) – Examina cómo los ensayos clínicos son llevadas a cabo, protección del paciente, el consentimiento informado y cómo encontrar ensayos clinicos disponibles. El tutorial se ofrece en 3 formas faciles de leer:  interactiva, auto-operada, o resumen de texto.
     http://www.nlm.nih.gov/medlineplus/spanish/tutorials/cancerclinicaltrialsspanish/htm/index.htm

    Administración de Alimentos y Medicamentos - (Federal Drug Administration)

    Preguntas y Respuestas Básicas Sobre Ensayos Clínicos (Participating in Clinical Trials) - Los ensayos clínicos son estudios voluntarios de investigación, realizados en humanos, diseñados para contestar preguntas específicas sobre la seguridad y/o eficacia de medicamentos, vacunas, otras terapias, o nuevas formas de utilizar los tratamientos existentes.
    http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/ucm142759.ht

    Estudios Clínicos (Clinical Trials) - Las direcciones preguntas comunes sobre los estudios clínicos, beneficios y riesgos, y el consentimiento informado.
    http://www.fda.gov/ForConsumers/ByAudience/ForWomen/FreePublications/ucm126282.htm

    Centro para la Información y el Estudio de Participación en Investigación Clínica (The Center for Information & Study on Clinical Research)

    *Los Hispanos y la Investigación Clínica (Education Before Participation) – Una versión concisa sobre la naturaleza de los ensayos clínicos, preguntas para hacer, derechos del participante, y beneficios y riesgos.
    http://www.ciscrp.org/patient/educ_materials/brochures/Brochure_Hispanics_web.pdf