Week 5: Getting Involved in Clinical Trials for Brain Research: 

What if you could help find the cure for Alzheimer's disease and other related dementias, just by volunteering? It may seem like a distant goal, but every major medical breakthrough in history has been built on the generosity of people who participated in a clinical trial. When you choose to participate in research, you become a central figure in the story of scientific discovery—a story that offers hope to millions of families. 

Think about every approved medication, every life-saving treatment, and every medical therapy we rely on today. From the aspirin in your cabinet to advanced therapies for heart disease and cancer, they all exist for one simple reason: people volunteered for clinical trials. Scientists can work for years in a laboratory, but only through studies with human volunteers can they learn if a new treatment is truly safe and effective. Without the partnership of people from the community, medical progress would come to a complete standstill. Clinical trial participants are the final, most crucial link in a long chain of discovery. They are the ones who help turn years of scientific research into real-world medical solutions that benefit everyone. They are the quiet heroes of medicine.

When you join a clinical trial, you are not just a "subject"—you are an active and respected partner in the scientific process. Your contribution is powerful in several ways:

• You Provide Essential Information. Your unique health data helps researchers understand how diseases progress and how new treatments work in different kinds of people. This knowledge is priceless.

• You Help Ensure Safety for All. By participating, you help researchers establish the safety and effectiveness of new treatments, ensuring they are ready for your children, your neighbors, and future generations.

• You Represent Your Community. It is vital for research studies to include people from all backgrounds. Your participation helps ensure that new medicines and treatments are effective for everyone, regardless of age, gender, or ethnicity.

• You Create a Legacy of Hope. Your contribution offers tangible hope to millions of families affected by brain diseases. It is a powerful way to fight back against conditions like Alzheimer's and dementia and to leave a lasting legacy of health for the future. 

A clinical trial is a research study involving human volunteers that is carefully designed to answer specific health questions. It is the safest and fastest way to find new methods to prevent, diagnose, and treat diseases. Participating in clinical trials for dementia represents the most significant pathway to new understanding, effective treatments, and ultimately, a cure. Here's why they are immensely important:

1. The Pathway to New Treatments and Cures: Clinical trials are the only way new medications, therapies, and preventive strategies can be scientifically tested, proven safe, and shown to be effective. Without them, there would be no new drugs to slow progression, manage symptoms, or one day, prevent or cure dementia. Every advancement in dementia care, from existing medications to future breakthroughs, originates in clinical trials.

2. Access to Cutting-Edge Care: For participants, clinical trials offer the opportunity to receive potential new treatments years before they might become widely available to the general public. This can provide hope and potentially a chance to benefit from therapies that are currently in development. Participants also receive close medical attention and monitoring from leading experts in the field.

3. Advancing Scientific Understanding: Beyond testing specific treatments, clinical trials provide invaluable data about the underlying causes and progression of dementia. Researchers learn more about the disease mechanisms, identify new biomarkers, and understand how various factors influence cognitive decline. This fundamental knowledge is critical for designing even better treatments in the future.

4. Contributing to Future Generations: Participating in a clinical trial is a profound act of altruism. Individuals who enroll contribute directly to a larger scientific effort that aims to improve the lives of countless others – their children, grandchildren, and future generations – who might otherwise face the devastating impact of dementia. Their participation accelerates the search for solutions.

5. Rigorous Oversight and Safety: Clinical trials are highly regulated and undergo strict ethical and scientific review. They are designed with participant safety as a top priority, with careful monitoring, informed consent processes, and clear protocols for managing any potential risks or side effects.

While the overall goal of any clinical trial is to improve health outcomes, trials in brain research have a particularly critical mission. Researchers and participants work together to:

• Find Better Therapies: Develop more effective treatments and potential cures for complex conditions like Alzheimer's disease, Parkinson's disease, Lewy Body dementia, and other neurodegenerative disorders.

• Discover Ways to Prevent Disease: Investigate new approaches, from medications to lifestyle changes, that could stop brain diseases before they even start.

• Improve Diagnosis: Create better tools for early and accurate diagnosis, which is key to managing symptoms and planning for the future.

• Understand the Healthy Brain: Deepen our knowledge of how a healthy brain works and ages. This provides a vital baseline that allows scientists to better understand what goes wrong during disease.

The decision to participate in research is a personal one. To help you make an informed choice, it's important to address some of the most common concerns and misconceptions about clinical trials.

Myth #2: "I might get a placebo and receive no real treatment."

Fact: While some trials use a placebo, your health is never compromised. You will always receive high-quality care.

A placebo is an inactive substance (like a sugar pill) that looks identical to the study drug. It is a vital scientific tool that helps researchers understand if a new treatment is genuinely effective by comparing the results of the two groups. However, it is important to know:

• Not All Trials Use Placebos. Many studies compare a new treatment directly to an existing, approved treatment (known as the "standard of care").

• Your Care Continues. In trials that do use a placebo, you are not left untreated. You will continue to receive the best available standard medical care for your condition, just as you would if you were not in the study.

• You Are Closely Monitored. All participants in a study, whether they are receiving the study drug or a placebo, are monitored very closely by a dedicated team of doctors and nurses.

Medical breakthroughs depend on the courage and generosity of volunteers. In the field of brain research, progress relies on two equally important types of participants: those who are living with a health condition and those who are in good health. Both are heroes who play a unique and indispensable role in the search for cures.

A. The Participant with a Health Condition

(For example, someone with Mild Cognitive Impairment, Alzheimer's, or Parkinson's Disease)

If you are living with a health condition, your participation in a clinical trial is a powerful way to take an active role in the fight against the disease.

• Your Role: Your primary role is to help researchers test if a new treatment, therapy, or diagnostic tool is safe and effective. By participating, you allow scientists to see firsthand how an intervention works to slow, stop, or even reverse the symptoms of a disease in the people it is designed to help.

• Your Impact: Your participation provides invaluable, real-world data on how a disease responds to therapy. This information is the bedrock upon which all medical progress is built. You are paving the way for a future where a diagnosis may no longer be a devastating event, creating a legacy of hope for the millions of people who will come after you.

• Potential Benefits: While not guaranteed for any individual, potential benefits of participating can include:

  • • Gaining access to cutting-edge, innovative treatments before they are widely available.

    • Receiving close monitoring and expert medical care from a team of specialists dedicated to your condition and well-being.

    • Feeling empowered by contributing directly to a solution.

B. The Healthy Volunteer

Healthy volunteers are the unsung heroes of medical research. Without their participation, many of the most important scientific questions could never be answered.

• Your Role: Your essential role is to serve as the "control" or "baseline" in a study. Your health data provides the "road map" of what is considered normal for factors like memory, blood markers, or brain scans. This allows researchers to clearly see the differences between changes caused by normal aging and those caused by a disease.

• Your Impact: Without data from healthy volunteers, it is impossible for scientists to know if a new treatment is truly effective or if an early diagnostic test is accurate. Your contribution is especially critical for prevention studies, which aim to stop diseases before they ever begin. Medical progress simply cannot happen without healthy volunteers.

• Potential Benefits: While you won't be receiving a treatment for a condition you don't have, the benefits of participating are significant:

  • • You often receive extensive health screenings (such as memory tests, blood work, or even brain scans) at no cost, providing valuable information about your own health.

    • You make a profound and lasting contribution to science.

    • You offer hope to friends, family, and community members who may be affected by a disease, now or in the future.

Whether you are managing a health condition or are in good health, your participation is a powerful gift. You are a partner in discovery, helping to turn scientific questions into the cures of tomorrow.

The primary purpose of compensation in clinical trials is not to "pay" someone to take risks, but rather to reimburse and acknowledge their contribution. It is a form of respect for the participant's time, effort, and expenses. The two main components of compensation are:

1. Reimbursement: This covers any direct, out-of-pocket costs a participant incurs.

2. Stipend: This is a payment that acknowledges the participant's time, inconvenience, and commitment to the study.

A.   What Does Compensation Typically Cover?

Compensation is carefully calculated to cover specific burdens associated with participating in a study.

• Time Commitment: This is often the largest factor. Participants are compensated for the time spent at the clinic, undergoing procedures, and completing any at-home tasks like diaries or questionnaires.

• Travel Expenses: This includes reimbursement for gas mileage, parking fees, tolls, or public transportation costs for getting to and from the study site. For longer visits, it may also include meals.

• Inconvenience and Effort: Many trials require a level of effort beyond simply showing up. This could include fasting before a visit, enduring uncomfortable procedures (like blood draws or injections), or following a strict medication schedule.

B.   How is the Amount Determined?

The amount of compensation varies significantly from one trial to another and is based on several factors:

• Number and Length of Visits: A trial with 20 short visits will likely offer more total compensation than a trial with two long visits.

• Types of Procedures: The level of invasiveness is a major factor. A study that only involves questionnaires will offer less compensation than one that requires multiple blood draws, a lumbar puncture (spinal tap), or PET scans.

• Overall Time Commitment: A study that lasts for three years with annual visits will have a different compensation structure than a high-intensity study that requires weekly visits for two months.

• Phase of the Trial: Early phase trials (Phase I), which are often conducted in healthy volunteers to test the safety of a new drug and may require overnight stays in a clinic, typically offer higher compensation due to the high level of commitment and inconvenience required.

C.   Ethical Considerations: The Role of the IRB

Compensation in clinical trials is highly regulated to ensure it is ethical. Every aspect of a study, including the amount and schedule of payments, must be reviewed and approved by and IRB. The IRB's main concern is to prevent "undue influence" or "coercion." This means the payment should not be so large that it could persuade someone to participate against their better judgment or ignore the potential risks of the study. The compensation should be a fair acknowledgment of their contribution, not an irresistible incentive.

D.   Practical Considerations

• How Payments Are Made: Compensation can be delivered in various ways, including checks, direct deposits, prepaid debit cards, or gift cards. The payment schedule (e.g., after each visit, monthly, or at the end of the study) will be clearly explained.

• Taxes: In the United States, payments from clinical trials are generally considered taxable income. If a participant receives $600 or more from a single institution in a calendar year, they will typically be issued a Form 1099. Participants should be aware of this potential tax liability.

• Insurance and Medical Costs: Compensation is separate from medical costs. The study sponsor is required to pay for all research-related procedures (like the experimental drug or special scans). Routine care that you would receive anyway may still be billed to your insurance. This is a crucial point that is detailed in the consent form.

All details about compensation—the amount, the payment schedule, and what it is intended to cover—are required to be clearly explained in the informed consent document that you review before agreeing to participate. This ensures you have all the necessary information to make a fully informed decision. 

The first step is to explore what studies are available. There are several trustworthy resources you can use to find world-class research happening right here in San Diego.

Where to Look:

• Local Research Centers: Many of San Diego's top research institutions have websites dedicated to their clinical trials. These are excellent places to start your search:

  • • UC San Diego Shiley-Marcos Alzheimer's Disease Research Center (ADRC)

    • The Salk Institute for Biological Studies

    • Sanford Burnham Prebys Medical Discovery Institute

    • Local hospitals and healthcare systems like Scripps Health and Sharp HealthCare.

• National Databases (Filtered for San Diego): You can also use large, reputable national databases and simply filter your search for the San Diego area.

  • • ClinicalTrials.gov: This is the most comprehensive database, run by the U.S. government.

      • • How to use: Visit the website and search for a condition (e.g., "Alzheimer's disease" or "memory loss") and enter "San Diego, CA" in the location field.

    • Alzheimer's Association TrialMatch®: This is a free, easy-to-use service that connects individuals with Alzheimer's disease, caregivers, and healthy volunteers to relevant trials in our area. 

Once you find a study you're interested in and contact the research team, the next step is a pre-screening. This is a brief, preliminary check to see if you might be a good fit for the study.

What to Expect:

• It's usually a simple phone call with a study coordinator or a short online survey.

• They will ask basic questions about your age, general health history, and current medications.

• The goal is to save you time by ensuring you meet the most fundamental requirements before you come in for a visit. This is also a great time for you to ask any initial questions you may have!

San Diego, California, is a significant hub for neuroscience and Alzheimer's disease research, with several institutions actively conducting cognitive clinical trials. If you are an older adult or know someone interested, participating can offer access to cutting-edge research and contribute to future breakthroughs. Here's a list of key institutions and examples of ongoing cognitive/dementia trials in the San Diego area. It's important to note that trial statuses (e.g., "recruiting," "not yet recruiting," "in progress, not accepting new patients") can change frequently, and eligibility criteria vary greatly.

Major Research Centers in San Diego Conducting Cognitive Trials:

1. UC San Diego Health / Shiley-Marcos Alzheimer's Disease Research Center (ADRC): This is a leading research center in the region, highly active in Alzheimer's and related dementias research, including observational studies and interventional clinical trials.

   • Website: You can often find their actively enrolling studies directly on their website: https://neurosciences.ucsd.edu/centers-programs/adrc/enrolling-studies/clinical-trials/index.html and https://clinicaltrials.ucsd.edu/alzheimers-disease

   • Contact: ADRC at 858-822-4800 or participate@ucsd.edu.

2. Sharp Neurocognitive Research Center: Part of Sharp HealthCare, this center focuses on finding treatments for neurocognitive disorders, including Alzheimer's disease, through clinical trials.

   • Website: https://www.sharp.com/services/mental-health/clinical-trials

   • Contact: 858-836-8350.

3. Alzheimer's San Diego (Local Chapter): This organization provides valuable resources, including a list of active clinical trials in San Diego County, and can often help connect individuals to suitable studies.

   • Website: https://www.alzsd.org/resources/san-diego-research/clinical-trials/

   • Contact: 858-492-4400.

4. Alzheimer's Disease Cooperative Study (ADCS) at UCSD: A major initiative for Alzheimer's disease clinical studies in the federal government, based at UC San Diego.

   • Website: https://www.adcs.org/clinical-trials/

5. Other Research Centers:

   • Excell Research (Oceanside, serves San Diego County): Conducts various clinical research studies, including for Alzheimer's disease. https://excellresearch.com/

   • Artemis Institute for Clinical Research: Conducts clinical trials for investigative medications for Alzheimer's disease. http://artemis-research.com/clinical_trials/alzheimers-disease/

   • The Neurology Center of Southern California: Also enrolling in studies for Alzheimer's disease.

Alzheimer's Disease and Memory Loss

• AHEAD Study: This study is for healthy older adults at risk for developing Alzheimer's. It tests whether an investigational treatment can help prevent or delay the onset of memory problems.

  • • Purpose: This is a groundbreaking prevention trial for healthy older adults (ages 55-80) who are at an increased risk of developing Alzheimer's disease in the future but do not have any memory problems. It tests whether an investigational treatment can help prevent or delay the onset of the disease.

    • How it Works: It uses amyloid PET scans to identify individuals with amyloid plaques in their brain, a key early sign of AD risk

    • Location: UC San Diego - Shiley-Marcos Alzheimer's Disease Research Center (ADRC)

• Trial-Ready Cohort for Preclinical/Prodromal AD (TRC-PAD): An observational study for individuals with normal cognition or mild memory changes to monitor them over time and build a group of people ready for future clinical trials.

  • • Location: UC San Diego Health

• A Study of Donanemab in Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 2): This trial evaluates the efficacy and safety of a drug designed to remove amyloid plaques in the brain in individuals with early-stage Alzheimer's.

  • • Location: Multiple sites, including some in the San Diego area.
      
      

Parkinson's Disease

• A Study of a New Drug to Reduce Levodopa-Induced Dyskinesia: This trial is for individuals with Parkinson's who experience involuntary movements (dyskinesia) as a side effect of their medication.

  • • Location: Scripps Clinic

• The Parkinson's Progression Markers Initiative (PPMI): A large-scale observational study seeking both people with Parkinson's and healthy volunteers to help identify biomarkers of disease progression.

  • • Location: UC San Diego Health

Participating in a clinical trial can be a powerful way to contribute to medical advancement and potentially access cutting-edge treatments. However, it's essential to understand the legal framework designed to protect you as a participant. Here are some key legal considerations to keep in mind.

The cornerstone of your legal protection in a clinical trial is the informed consent process. This is more than just signing a form; it's an ongoing conversation between you and the research team. Before you agree to participate, the research team is legally and ethically obligated to explain all aspects of the study, including:

• Purpose and Procedures: What the study is trying to discover and what you will be asked to do.

• Potential Risks and Benefits: A clear explanation of any known risks, side effects, and potential benefits to you or others.

• Alternative Treatments: Information about other available treatment options.

• Confidentiality: How your personal health information will be protected.

• Voluntary Participation: A clear statement that you can leave the trial at any time for any reason without penalty.

You must be given a written informed consent document that details this information, and you should have ample opportunity to ask questions and discuss it with your family and personal doctor before signing.

Every clinical trial in the United States must be reviewed, approved, and monitored by an Institutional Review Board (IRB). An IRB is an independent committee made up of scientists, doctors, and community members. Their primary responsibility is to protect the rights and welfare of human research subjects.

The IRB reviews the study's protocol to ensure that:

• Risks to participants are minimized and are reasonable in relation to potential benefits.

• The selection of participants is fair and equitable.

• Informed consent is obtained and documented correctly.

• There are adequate provisions for monitoring the data to ensure safety.

The IRB's oversight provides a crucial layer of protection for participants throughout the duration of the study.

• Clinical trials are safe, highly regulated, and essential for all medical advances.

• Both people with a condition and healthy volunteers are vital partners in research.

• San Diego is a leader in brain research with many opportunities to get involved.

• Encourage friends and family members to think about participation as a powerful way to contribute to the health of future generations.

• To find a comprehensive and up-to-date list of all recruiting trials, the best resources are

  • • ClinicalTrials.gov (the official U.S. government database)

    • https://atri.usc.edu/studies/

Institutional Review Boards and History of Clinical Trials

1. Sengupta S, Lo B. The roles and experiences of nonaffiliated and non-scientist members of institutional review boards. Acad Med. 2003;78(2):212-218.

2. Catania JA, Lo B, Wolfe LE, et al. Survey of U.S. Human Research Protection Organizations: workload and membership. J Empir Res Hum Res Ethics. 2008;3(4):57-69.

3. National Institutes of Health. Guidelines for the conduct of research involving human subjects at the National Institutes of Health. 2004. http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf. Accessed March 9, 2009.

4. Where it All Began: The History of Clinical Research

National Databases and Resources

• ClinicalTrials.gov: The most comprehensive database of clinical studies conducted around the world, run by the U.S. government.

  • • • Website: https://www.clinicaltrials.gov
        
        

  • Alzheimer's Association TrialMatch®: A free service that connects individuals, caregivers, and healthy volunteers with clinical trials.

    • • Website: https://www.alz.org/alzheimers-dementia/research_progress/clinical_trials/trialmatch
        
        

San Diego Research Centers and Organizations

• UC San Diego Health / Shiley-Marcos Alzheimer's Disease Research Center (ADRC): A leading research center in the San Diego region for Alzheimer's and related dementias research.

  • • • Website for Enrolling Studies: https://neurosciences.ucsd.edu/centers-programs/adrc/enrolling-studies/clinical-trials/index.html

      • General Clinical Trials Website: https://clinicaltrials.ucsd.edu/alzheimers-disease

• Alzheimer's Therapeutic Research Institute (ATRI): A San Diego-based institute that designs, manages, and leads major, multi-site clinical trials for Alzheimer's disease6666.

  • • • Website: https://atri.usc.edu/studies/

• Sharp Neurocognitive Research Center: A center within Sharp HealthCare that conducts clinical trials to find treatments for neurocognitive disorders.

  • • • Website: https://www.sharp.com/services/mental-health/clinical-trials

• Alzheimer's San Diego: The local chapter that provides resources and lists of active clinical trials in San Diego County.

  • • • Website: https://www.alzsd.org/resources/san-diego-research/clinical-trials/

• The Salk Institute for Biological Studies

  • • • Website: https://www.salk.edu

• Sanford Burnham Prebys Medical Discovery Institute

  • • • Website: https://www.sbpdiscovery.org

• Excell Research (Oceanside): A research center serving San Diego County that conducts clinical studies for conditions including Alzheimer's disease.

  • • • Website: https://excellresearch.com/

• Artemis Institute for Clinical Research: Conducts clinical trials for investigative Alzheimer's medications.

  • • • Website: http://artemis-research.com/clinical_trials/alzheimers-disease/

• The Neurology Center of Southern California: Enrolls participants in Alzheimer's disease studies.

  • • • Website: https://www.neurocenter.com/

Foundations and National Initiatives

• • Global Alzheimer’s Platform Foundation (GAP): Developer of the Acti-v8 Your Brain program, which aims to increase awareness of activities that reduce cognitive decline risk19.

    • • Website: https://globalalzplatform.org/activ8yourbrain/

• • Alzheimer's Clinical Trials Consortium (ACTC): A major national network for Alzheimer's trials, co-led by ATRI.

    • • Website: https://www.actcinfo.org/

• • Alzheimer's Disease Cooperative Study (ADCS) at UCSD: A major federal government initiative for AD clinical studies, based at UC San Diego.

    • • Website: https://www.adcs.org/

• • The Parkinson's Progression Markers Initiative (PPMI): A large-scale observational study to identify biomarkers of Parkinson's disease progression.

    • • Website: https://www.ppmi-info.org/