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Home My WebLink AboutI. A. AHEAD EASTERN VIRGINIA MEDICAL SCHOOL (EVMS) STUDY 4.16.24Facts You Should Absolutely Know about Alzheimer’s Disease AHEAD STUDY TEAM – Eastern Virginia Medical School DR. ETHLYN MCQUEEN-GIBSON, DNP, MSN, RN-BCNORFOLK STATE UNIVERSITY DR. HAMID OKHRAVI, MDEASTERN VIRGINIA MEDICAL SCHOOL DR. BAHAR NIKNEJAD, MDEASTERN VIRGINIA MEDICAL SCHOOL Virginia Beach City Council April 16, 2024 Outline •Dementia vs. Alzheimer’s vs. normal forgetfulness •Clinical trials •AHEAD Study; a prevention clinical trial 2 What is Cognition? – Brain Health •The process of knowing, being aware, thinking, learning and judging •Memory is important •Cognition also includes: •Attention •Language •Executive function (mental skills that help an individual plan, monitor, and successfully execute their goals •Visuospatial skills Visuo-spatial Executive function 3 How Normal Aging and Dementia Compare? Normal Aging •Making a bad decision once in a while •Missing a monthly payment •Forgetting which day it is but remembering later •Sometimes forgetting which word to use •Occasionally losing things Dementia •Poor judgement and decision making inability to manage budget or handle finances •Losing track of the day or the season •Difficulties having a conversation •Misplacing or losing items frequently Dementia: Impaired ability to remember, think, or make decisions that interferes with doing everyday activities 4 Lewy Body Dementia Alzheimer’s Dementia Vascular Dementia Parkinson’s Dementia Frontotemporal Dementia Dementia 5 Hallmarks of AD Pathology Amyloid plaques: Amyloid deposition NFT: Neurodegeneration 6 ventricles hippocampus Normal Alzheimer’s 7 Subjective Cognitive Decline (SCD): Who Should Seek Medical Evaluation? •Age of onset > 60 years •Perception that performance is worse than peers •Persistence or worsening of SCD over time •Confirmation of decline by an informant •Family history of dementia or Alzheimer’s •Multiple cardiovascular risk factors 8 How Do We Differentiate Between Normal and Abnormal Cognitive Decline? •Obtaining comprehensive history from patients and informants •Pen and paper memory test (Neuropsychological testing) •Brain imaging: •MRI •Amyloid PET imaging (over 90% accuracy) •Spinal tap •Alzheimer’s disease biomarkers (over 90% accuracy) 9 Amyloid PET Imaging Negative amyloid imaging Alzheimer’s disease •Not covered by Medicare or other insurers •Cost: $10k •Diagnostic accuracy: 90-95% •Available free of charge in several studies (AHEAD Study, New IDEAS, REPHRASE) 10 CLINICAL TRIALS Facts and Figures 2021 12 GENDER, RACIAL & ETHNIC DISPARITIES IN ALZHEIMER’S PREVALENCE & TRIALS Almost two-thirds of Americans with Alzheimer’s are women. Older Black and Hispanic Americans are disproportionately more likely than older Whites to have Alzheimer’s or other dementias. Ethnoracial groups have been historically underrepresented in clinical studies, underscoring the need for more diversity in dementia research. Facts and Figures 2021 13 What is a Clinical Trial? •A clinical trial is part of clinical research and at the heart of all medical advances •Looks at new ways to prevent, detect, or treat disease •The goal of a clinical trial: •To determine if a new test or treatment works and is safe •Can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses such as Alzheimer’s 14 Reasons to Participate in Clinical Trials •To help others and to contribute to moving science forward •To help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff •Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future 15 Things You Should Know/Ask Before Joining a Clinical Trial •What is the purpose of the study? •How long the study last and what will be my responsibilities? •How are safety of participants being monitored? •How long the study last and what happens after that? •What are my possible short-term & long-term benefits/risks? •What kind of therapies or tests will I have during the study? •Will I have to pay for the study drugs or tests? •How is safety and privacy protected? 16 Tips for Asking Your Doctor About Trials •Consider taking a family member or friend along for support and for help in asking questions or recording answers •Plan what to ask — but don't hesitate to ask any new questions •Write down questions in advance to remember them all •Write down the answers so that they’re available when needed 17 Alzheimer’s Disease Prevention Trial 18 Alzheimer’s Disease Spectrum AD Dementia MCI AD Preclinical AD AHEAD Study 19 AHEAD Study A new Alzheimer ’s prevention study called the AHEAD Study is testing whether a new treatment delays memory decline in people up to 20 years before symptoms appear Why 20 years? 20 Preclinical AD (Before Symptoms Start): Optimal for More Effective Treatment •It is possible to accurately identify AD at the preclinical stage prior to substantial irreversible damage to our brain •i.e., elevated brain amyloid plaques with no symptoms •Intervention prior to dementia stage (irreversible brain cell loss) may have better chance of changing clinical course •Think about what happens in other disease processes such as cancer, … if we wait to treat until after symptoms appear? 21 AHEAD Study: Two Different Clinical Trials •Study participants are enrolled in one of two AHEAD trials based on the level of amyloid plaques in their brain: •AHEAD A3 Trial: •Participants with intermediate level of amyloid plaques •The first ever trial aimed at stopping the earliest signs of AD •Participants will receive Lecanemab once every 4 weeks for 4 years •AHEAD A-45: •Participants with elevated level of amyloid plaques •Will receive Lecanemab once every 2 weeks for about 2 years and then once every 4 weeks for the remainder of the study 22 AHEAD Study Organizers & Sites •Funded by: •National Institute of Health •Several philanthropic organizations •Eisai •Sites: •100 sites, including 75 North American sites •Eastern Virginia Medical School (EVMS) is an active site 23 First of Its Kind to: •Enroll participants as young as 55 years old who are at risk of developing symptoms of AD as they get older •Target the earliest changes in the brain due to AD by enrolling participants with intermediate levels of brain amyloid plaques •Tests an investigational treatment that has been shown to slowing the memory loss in people with symptoms of AD 24 Lecanemab Treatment in a Research Participant with Alzheimer’s Disease 25 Who is Eligible? • Adults, ages 55 - 80 • Have not been diagnosed with Alzheimer’s disease, but may be worried about memory loss in the future • Agree to a four-year commitment • Have a study partner 26 SUMMARY: WHAT ARE SOME STEPS YOU CAN TAKE FOR GOOD BRAIN HEALTH: 27 Questions