Clinical Trials at the RHCW
The RHCW conducts research through clinical trials as part of our mission to improve Heart Health and Brain Health. The trials conducted at RHCW are designed to test the safety and effectiveness of innovative new treatments and medications for patients in addition to maintaining cognitive health and memory functioning.
Through clinical trials, we gain answers to important questions about the prevention, diagnosis, and treatment of many different types of medical conditions. The clinical trials underway at the RHCW are vital to advance the science of medicine and to generate knowledge and discoveries that translate to the development of new medicines and therapies for Cardiovascular disease and optimal Brain Health.
Choosing to participate in a clinical trial or research study is an important personal decision. Before you join or your loved one joins a research trial or study, your doctor should talk to you about what it’s like to be in a trial and describe the pros and cons of participating.
If you are interested, someone from the clinical trial staff will explain the details of the study, risks and benefits, and your rights as a participant, including your right to withdraw from the study at any point. Once all your questions have been answered, they will ask you to sign an informed consent to participate.
The following frequently asked questions (FAQ) provide detailed information about clinical trials and were modified from the NIH Clinical Trials website, and the National Institute on Aging Alzheimer’s Disease Education and Referral (ADEAR) Center.
If you would like more information, you may find the booklet, Clinical Trials, and Older Adults, published by the National Institute on Aging helpful for describing how older adults can volunteer for research studies.
What are the Different Types of Trials?
Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
What are the Phases of Trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20–80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100–300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (1000–3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post-marketing studies note additional information including the drug’s risks, benefits and optimal use
The RHCW has been participating in clinical trials for many years, and with its focus on Heart and Brain and Cognitive Health has focused on trials that seek to optimize heart health and prevent cognitive decline and dementia.
From the initial piloting of cognitive tests delivered on an iPad through the BrainFX study to recruiting and enrolling patients in NIH-funded lifestyle studies, that utilize online cognitive programs such as CogState or BrainHQ, the RHCW is committed to offering our patients studies with innovative study designs.
We continue to partner with colleagues from the Departments of Internal Medicine, Neurological Sciences, Nursing, the MIND Center for Brain Health, and the Rush Alzheimer’s Disease Center Clinical Trial Section, to actively recruit and refer our patients to clinical trials for the prevention of cognitive decline, mild cognitive impairment or Alzheimer’s disease.
Through our Collaborations with multi-center NIA-funded Consortia groups, our collaborative network extends throughout the country.
Watch this video about Why Trials are Important
Your participation in studies helps us evaluate potential therapies. If one of the trials looks interesting to you, please talk with your doctor or contact the study team to see if it is appropriate for you.
Want more information?
You may find the booklet, Clinical Trials, and Older Adults, published by the National Institute on Aging helpful for describing how older adults can volunteer for research studies. You can also check the NIH site, ClinicalTrials.gov to see all studies that are being conducted.
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The Alzheimer’s Prevention Trials Web study (APT)
This is an online memory and thinking research tool aimed at accelerating enrollment into Alzheimer’s clinical trials, by identifying and tracking individuals who may be at higher risk for developing Alzheimer’s.
Click here for a printable flyer
Who is eligible to participate?
- Anyone 50 years of age or older
- Because this study is online, you can complete this study from anywhere at any time.
Want to sign up? Click here to sign up
What should I expect?
Participants will have their memory assessed every 3 months and will be tracked over time, all online. If it is found that you are at increased risk for developing Alzheimer’s, you may be invited for an in-person evaluation that may include additional memory tests, brain scans, and blood tests.
Your in-person evaluation would occur at the Rush Alzheimer’s Disease Center (RADC) at Rush Main Campus.
If eligible after this evaluation, you will then be provided the opportunity to enroll in a clinical trial aimed at preventing the cognitive decline associated with Alzheimer’s through the RADC Trial Section.
What is the benefit of participating in this study?
APT Web study participants benefit by:
- Having their cognitive health assessed over time in the comfort of your home
- Being on the ‘fast track’ for relevant clinical trials to prevent Alzheimer’s
- Making an invaluable contribution to advancing Alzheimer’s research, perhaps helping those in the research field find the first Alzheimer’s survivor
- Helping ensure that future generations do not experience Alzheimer’s and its difficult challenges.
The Study Collaborators for this Trial
- Funded by:
- University of Southern California’s Alzheimer’s Therapeutic Research Institute (USC ATRI: Keck School of Medicine) and the National Institute on Aging (NIA)
- In Partnership with:
- Brigham and Women’s Hospital, Cleveland Clinic
- Rush Leads:
- Neelum T. Aggarwal, MD/ Site Principal Investigator
- Departments of Neurological Sciences, Rush Alzheimer’s Disease Center-Trial Section
- Annabelle Volgman, MD / Medical Director, RHCW
- Departments of IM – Section of Cardiology
- Neelum T. Aggarwal, MD/ Site Principal Investigator
Trial Ready Cohort for the Prevention of Alzheimer’s Dementia (TRC-PAD)
Those identified to have potential increased risk for memory loss caused by Alzheimer’s disease will be referred from the APT Web study to the Trial Ready Cohort for the Prevention of Alzheimer’s Dementia (TRC-PAD) in-person study.
The purpose of TRC-PAD is to find as many people as possible (also called a “cohort”) who are interested in participating in clinical trials aimed at discovering treatments that will reduce the risk of developing Alzheimer’s dementia.
TRC-PAD will help researchers enroll participants into these trials quickly to allow new treatments to be discovered as soon as possible. Participants do not have to participate in the TRC-PAD study in order to participate in the online APT Web study.
Click here for a printable study guide brochure
Want more information about this study?
Please call the Rush Alzheimer’s Disease Center Clinical Trial Section at (312) 942 0050
The Study Collaborators for this Trial
- Funded by:
- University of Southern California’s Alzheimer’s Therapeutic Research Institute (USC ATRI: Keck School of Medicine) and the National Institute on Aging (NIA).
- In Partnership with:
- Brigham and Women’s Hospital, Cleveland Clinic
- Rush Leads:
- Neelum T. Aggarwal, MD/ Site Principal Investigator
- Departments of Neurological Sciences, Rush Alzheimer’s Disease Center-Trial Section
- Annabelle S. Volgman, MD / Medical Director, RHCW
- Departments of IM – Section of Cardiology
- Neelum T. Aggarwal, MD/ Site Principal Investigator
AHEAD Study
The AHEAD study is a large multicenter trial aimed at preventing memory loss due to Alzheimer’s disease. This study is for people who may be at risk for memory problems.
The purpose of the study is to see if the drug BAN2401 (lecanemab) can help reduce the risk of developing Alzheimer’s disease dementia. The amyloid build-up may lead to impairment in memory and thinking and is often found in people with Alzheimer’s disease. BAN2401 (lecanemab) is a human antibody that binds to amyloid proteins in the brain.
This drug is not FDA-approved and is investigational.
Participants are randomly assigned to receive the investigational study drug or placebo (a non-active agent used for comparison). The drug or placebo is given by an intravenous infusion.
Based on imaging results, participants will be assigned to one of two arms of the study. One arm will receive the drug or placebo twice per month and the other arm will receive the drug or placebo once per month.
This study is approximately four years in length.
Who is eligible to participate?
Healthy individuals 55-80 years of age who are cognitively normal.
Participants must have a reliable study partner: a spouse, relative, or friend who knows the participant well and sees him or her often, who will attend some study visits, and who will provide information about the participant during the study.
What should I expect?
Participants will be screened over multiple visits to determine eligibility. The screening includes:
- A physical and neurological exam
- Medical history and medication review
- Collection of blood and urine
- ECG/EKG
- Assessments of your memory, thinking, mood and well-being
- Brain MRI and PET scans
After the screening, study activity includes:
- One “baseline” visit, then, depending on what arm of the study the participant is assigned to, infusions spaced out over four years at the Rush Alzheimer’s Disease Center
- MRIs, memory and thinking tests, blood and urine collection, and assessments of mood and well-being
Please visit www.aheadstudy.org to learn more about the study
Contact Us for More Information
Rush Alzheimer’s Disease Center Trial Section at (312) 942-0050
What is the benefit of participating in this study?
AHEAD study participants benefit by:
- Helping us understand how Alzheimer’s disease develops in the brain before symptoms appear, and hopefully contribute to one day finding a treatment to prevent memory loss due to Alzheimer’s disease.
- Working closely with world-renowned academic researchers located in cities across the United States and Canada.
- Being involved in a study that uses a personalized medicine approach, tailoring dose levels of the investigational treatment to study participants’ brain amyloid levels.
- Test a medication that has been shown to lower brain amyloid in people with symptoms of Alzheimer’s.
- AHEAD’s Statement Fostering Diversity and Inclusion
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- Alzheimer’s disease affects everyone, everywhere. People of every race and ethnicity are needed for this study.
- Some communities, such as African American/Black and Latino/a individuals, may be at higher risk for Alzheimer’s disease, but are underrepresented in research.
- The AHEAD Study needs participants of every race and ethnicity to find a treatment for Alzheimer’s disease that works for everyone. Help find answers that benefit your community by participating in the AHEAD Study.
The Study Collaborators for this Trial
- Funded by:
- University of Southern California’s Alzheimer’s Therapeutic Research Institute (USC ATRI: Keck School of Medicine) and the National Institute on Aging (NIA) and Eisai.
- In Partnership with:
- Brigham and Women’s Hospital, Mass General Hospital, Harvard Medical School
- Rush Leads:
- Neelum T. Aggarwal, MD/ Site Principal Investigator
- Departments of Neurological Sciences, Rush Alzheimer’s Disease Center-Trial Section
- Annabelle Volgman, MD / Medical Director, RHCW
- Departments of IM – Section of Cardiology
- Neelum T. Aggarwal, MD/ Site Principal Investigator
The US POINTER Study
The U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) is a two-year research study to see if lifestyle changes focused on improving risk factors can protect memory and thinking ability (cognition) as we age. The study will enroll 400 voluntary participants in the Chicago area and 2,000 volunteers across the country.
Who is eligible to participate?
- People between the ages of 60 and 79
- People who have normal cognition (no memory problems)
- People who are not regular exercisers (generally less than 3 times per week)
- People whose current health status may put them at increased risk of memory loss in the future, such as a family history of memory problems, slightly high blood pressure, cholesterol, or blood sugar
Want to Learn More?
Call or email the Rush POINTER Team
Phone: 1.708.660.6463
Email: [email protected]
What should I expect?
Two lifestyle interventions, which vary in intensity and format, will be compared.
Eligible volunteers will be randomly assigned (like the flip of a coin) to one intervention group to evaluate whether cognitive benefits from a structured program differ from a self-guided program.
Both groups will receive information, tools, and support to add lifestyle changes, including physical exercise, a healthy diet, and thinking (cognitive) exercises. One main goal of the study is to work together to develop a healthy lifestyle program that can continue in our community – and across the United States – for everyone long after the study has ended.
What is the benefit of participating in this study?
By Joining the US POINTER study, participants benefit by:
- Participating in a unique study design, initially done in Finland (the “FINGER” study) that showed a lifestyle program that combined physical exercise, healthy eating, brain exercises, and health monitoring protected memory and other thinking abilities in older adults who were at increased risk of memory loss.
The Study Collaborators for this Trial
- Funded by:
- Alzheimer’s Association/ National Institute on Aging (NIA)
- Rush Leads:
- Christy Tangney, Ph.D./ Site Principal Investigator
- Departments of Preventive Medicine and College of Nutrition Science
- Annabelle S. Volgman, MD / Medical Director, RHCW
- Departments of IM – Section of Cardiology
- Neelum T. Aggarwal, MD/ Research Director, RHCW
- Departments of Neurological Sciences, Rush Alzheimer’s Disease Center-Trial Section
- Christy Tangney, Ph.D./ Site Principal Investigator
U.S. POINTER Ancillary Studies
If you successfully enroll in the US POINTER Study, you will be asked to consider joining add-on studies. The U.S. POINTER add-on studies look deeper into the science of the main study.
The Neuroimaging Ancillary study is the first large-scale investigation of how lifestyle interventions affect biological changes in the brain associated with Alzheimer’s and dementia.
The U.S. POINTER Neuroimaging Ancillary Study
The Sleep Ancillary study will examine whether changes in sleep predict changes in overall cognitive function or in specific areas, such as memory.
The U.S. POINTER-zzz Sleep Study
The Study Collaborators for this Trial
- Rush Leads:
- Neelum T. Aggarwal, MD/ Neuroimaging Site Principal Investigator
- Departments of Neurological Sciences, Rush Alzheimer’s Disease Center-Trial Section
- Pankaja Desai, Ph.D./ Sleep Study Site Principal Investigator
- Departments of IM – Rush Institute for Healthy Aging
- Annabelle S. Volgman, MD / Medical Director, RHCW
- Departments of IM – Section of Cardiology
- Neelum T. Aggarwal, MD/ Neuroimaging Site Principal Investigator
The MindMoves Clinical Trial
Who is eligible to participate?
- Women aged 65 years of age or older
- Not exercising regularly
- Not participating in cognitive training computer games
What should I expect?
MindMoves combine two evidence-based interventions. MIND is the cognitive training program BrainHQ delivered in an electronic tablet format. Move is lifestyle physical activity intervention from the Women’s Lifestyle Physical Activity Program
The entire intervention is 24-weeks with data collection at baseline, 24 weeks, 48 weeks, and 72 weeks.
What is the benefit of participating in this study?
Participants can do all visits from home with safe limited in-person visits
Compensation: Up to $160 for completing the study and a FitBit
The Study Collaborators
- Funded by: National Institute of Nursing Research (NINR)
- Rush Leads:
- Shannon Halloway, Ph.D. / Principal Investigator
- Department of Nursing
- Annabelle Volgman, MD / Medical Director, RHCW
- Department of Internal Medicine – Section of Cardiology
- Shannon Halloway, Ph.D. / Principal Investigator