We’re looking for people with a family history of dementia interested in being part of a study that could make strides in Alzheimer’s disease and related dementias research
WHAT IS THIS STUDY ABOUT?
WHY PARTICIPATE?
WHO CAN PARTICIPATE?
WHAT CAN YOU EXPECT?
INTERESTED?
FAQs about the study itself:
Why are we doing this study?
Researchers from HudsonAlpha Institute for Biotechnology and their collaborators are trying to learn more about genetic and lifestyle risk factors for Alzheimer’s disease and related dementias (ADRD) and determine whether certain lifestyle modifications can lower a person’s risk for disease.
What are the study goals?
This study has several important goals:
- Pilot Testing a Prevention Program: We will explore how lifestyle changes might help reduce dementia risk. We’re also testing the best ways to collect and use data for future dementia prevention programs.
- Improving Dementia Risk Knowledge: We aim to better understand the specific factors contributing to dementia risk.
- Understanding Risk Perception: We want to learn how individuals’ attitudes about their dementia risk change as they receive personalized risk information and learn about potential lifestyle modifications.
Who is conducting this study?
HudsonAlpha Institute for Biotechnology, in collaboration with Phenome Health and the Buck Institute for Research on Aging.
FAQs about participation:
Who can participate?
Adults aged 65-75 with no current cognitive impairment (no diagnosis of “mild cognitive impairment” [MCI], dementia, or Alzheimer’s disease) and who have at least one first-degree relative (parent, sibling, or child) who has or had Alzheimer’s disease or related dementias.
Why should I participate?
By joining this study, you may learn about your risk for dementia. Your participation may lead to discoveries that help advance medical research and improve participant care in the future.
How do I participate?
Contact the staff at Smith Family Clinic for Genomic Medicine to determine if you are eligible to participate at HOPEADstudy@hudsonalpha.org or call the office at 256-327-9640. If you meet the eligibility criteria, our staff will schedule your screening appointment (subject to availability of remaining participant recruitment slots).
I don’t qualify to participate, but I’d like to help. How can I support the project?
If you’re not eligible to participate but want to help, sharing the study with your friends and family spreads awareness about this work and could help enroll eligible participants. You may also make a donation to support the project by contacting the HudsonAlpha Foundation at foundation@hudsonalpha.org or 256-327-0422.
Will I incur medical fees or bills if I participate in the study?
You will have no cost to participate in this study. In addition, you will receive nominal compensation for your time if you’re selected to participate after the initial screening.
What will I do in the study?
You’ll begin with a visit to the Smith Family Clinic for Genomic Medicine on the HudsonAlpha campus. There, you’ll complete questionnaires about your personal and family health history, take a cognitive assessment, have a brief physical check-up, and complete a cheek swab for Alzheimer’s-related genetic risk testing. We’ll also ask you to have a blood sample taken within a week of your visit at a local Labcorp location.
If your initial assessments indicate an increased risk for future development of Alzheimer’s disease and related dementias, we’ll ask you to remain in the study. You will receive personalized coaching on healthy eating, sleep and lifestyle habits, activity tracking to help you stay active, and brain training exercises to support cognitive function.
What is a cognitive assessment?
A cognitive assessment is a brief test that helps us understand how well the brain is functioning. This study will use the Montreal Cognitive Assessment (MoCA) test. It is a simple, 10-minute test widely used to evaluate different aspects of cognition, like memory, attention, and language.
How will activity tracking be performed?
If you qualify to remain in the study based on an increased risk for future development of Alzheimer’s disease and related dementias, you will be asked to wear a fitness tracker to record your daily activity.
What is brain training?
Brain training involves exercises and activities designed to improve specific cognitive skills, such as memory, attention, and processing speed. In this study, we’ll use BrainHQ, a scientifically developed online program with exercises that can help strengthen the brain.
How long does the study last? / What is my time commitment?
The initial screening appointment should take an hour, plus the time to get your blood drawn at Labcorp.
If you qualify to remain in the study after the screening, you will participate in monthly calls with your assigned health coach, commit to 150 minutes/week of moderate physical activity, engage in cognitive training via Posit’s BrainHQ web-based training tools, and attend at least two follow-up appointments at the Smith Family Clinic.
If you remain in the study after screening, your participation will last about six months from your first follow-up visit at the Smith Family Clinic.
Are any in-person study visits required?
Yes, this study requires in-person visits.
- Initial screening visit: Your first visit will be at the Smith Family Clinic for Genomic Medicine (SFC) on HudsonAlpha’s campus.
- Lab visit(s): Everyone screened for participation must visit a local Labcorp location once for a blood draw. Those selected to continue in the study will visit Labcorp for two additional blood draws.
- Full Study Visits (if eligible): If you qualify for the full study, you must return to SFC at least two more times during the study.
Do I have to share my health information to participate?
Yes, we will ask you to share your family and personal health history to the best of your knowledge. We are committed to protecting your privacy and handling your information securely. Importantly, participation in the study is voluntary, and you may choose not to participate.
How will my personal and health information be protected?
Your privacy is our top priority. All personal and health information collected during this study will be confidential. We will use secure data storage systems and adhere to all applicable privacy laws and regulations. Only authorized clinic staff will have access to your identifying information. We will also de-identify data whenever possible to further protect your privacy.
Does my physician have to be involved/order tests/etc.?
No, you can participate in this study without the involvement of your medical providers. However, if you receive results indicating an increased risk for Alzheimer’s disease or other abnormal clinical laboratory results, you may choose to share them with your medical providers for further guidance and support.
What are the potential risks?
All participants will have blood drawn for clinical and research tests and analyses. Like any blood draw, there is a possibility of mild pain or bruising at the draw site and a minimal risk of infection.
Clinical test results may identify one or more genetic variants, signatures, or biomarkers that could indicate an increased risk for dementia. Learning this information could be emotionally challenging for some individuals. We will provide thorough genetic counseling before you consent to the study, explaining the type of information you may receive and the potential emotional effects of receiving this information.
FAQs about the results/information being collected/returned:
Will the results of the study be returned to me?
Yes, all participants, regardless of whether they qualify for the full study, will receive results related to these genetic risk factors and biomarker indicators for Alzheimer’s disease:
- APOE status- a well-known gene linked to Alzheimer’s risk
- Polygenic risk score- an analysis that combines multiple genes to provide a more complete picture of disease risk
- pTau217 protein levels- a brain protein, or “biomarker,” known to be elevated in early Alzheimer’s disease
HudsonAlpha will provide the published aggregated study results (once available) at the study participants’ request.
What is a biomarker?
Biomarkers, short for biological markers, are characteristics measured to determine health status, disease presence and progression, or treatment effects. For this study, we are looking at specific biomarkers in your blood, some of which are known to be elevated in early Alzheimer’s disease.
What is a polygenic risk score?
In this study, a polygenic risk score is a tool that helps us understand your genetic risk for Alzheimer’s disease. It’s calculated by analyzing many genetic changes in your DNA, which can provide a more comprehensive picture of your genetic predisposition than looking at single genes. This risk is then compared to the general population’s risk for Alzheimer’s disease, and you receive a percentile score for risk.
What is phenomics?
This study uses a “phenomic” approach by capturing highly detailed data about participants’ health, environment, biomarkers, and lifestyle. Phenomics is a field of study that aims to measure and analyze a broad range of observable characteristics of an individual. By studying these factors together, we can gain a more complete picture of the factors that influence brain health.
Who should I contact if I have questions?
To learn more, contact staff at the Smith Family Clinic for Genomic Medicine via email at
HOPEADstudy@hudsonalpha.org or call the office at 256-327-9640.
20250931
#43229551.0
IRB Approved at the Protocol Level
Apr 16, 2025