Participant Resources

Although the journey living with Alzheimer’s disease can be filled with a variety of ups and downs, you’re not alone. Some of the resources and support that can help you along the way are listed below.

Clinical Research Resources

A Guide to Costs and Payments in Clinical Trials

Learn the basics about costs and payments in clinical research. This brochure also suggests some specific questions to ask the study doctors and staff.
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African Americans and Clinical Research

Learn more about why participation in clinical research is important for the African American community.
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Alzheimer’s Disease Support

The Alzheimer’s Association has a goal to end Alzheimer’s and all other dementia—by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support.
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The BrightFocus Foundation funds groundbreaking research in an urgent effort to discover cures for Alzheimer’s disease, macular degeneration, and glaucoma.
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Frequently Asked Questions (FAQs)

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A clinical research study, also known as a clinical trial, is a medical study that is designed to answer questions about the safety of potential new medicines and to find out how well they work. All potential drugs or medicines must be studied before they can be approved for use in patients and made available to the public.

It is important to test medicines in the people they are meant to help. It is important that research includes a variety of people, because different people may respond differently to medicines.

Participant safety and welfare is always the most important aspect of any research study. As a result, studies are highly regulated with safeguards in place by both the study sponsor and by the Institutional Review Board (IRB) or Ethics Committee (EC). Research studies are also overseen by governmental agencies, such as the Food and Drug Administration in the United States, to protect the rights and welfare of volunteers.

Once a research study begins, the IRB/EC watches over it in case there are any problems. If you are in a research study, you can contact the IRB/EC with any questions or concerns.

Study centers will follow recommended local and federal clinical guidelines.

If you qualify for and agree to participate in the study, you will receive all study-related medicines and study-related care at no cost. In addition, reimbursement for study-related travel expenses may be available.

When the research study is over, the sponsor may seek to publish the results (in a scientific journal, for example). Study results will also be posted on ClinicalTrials.gov after all study participants have completed the study and study data has been analyzed. Your identity will remain confidential. Only overall summary data results from participants will be publicly shared. Research results will never contain your name and will never publicly report your individual data.

Research studies are designed in specific ways to test investigational medicines for safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for the study. This does not mean you will not qualify for different research studies.

What is a clinical research study?

A clinical research study, also known as a clinical trial, is a medical study that is designed to answer questions about the safety of potential new medicines and to find out how well they work. All potential drugs or medicines must be studied before they can be approved for use in patients and made available to the public.

It is important to test medicines in the people they are meant to help. It is important that research includes a variety of people, because different people may respond differently to medicines.

Are there safety measures for clinical research study participants?

Participant safety and welfare is always the most important aspect of any research study. As a result, studies are highly regulated with safeguards in place by both the study sponsor and by the Institutional Review Board (IRB) or Ethics Committee (EC). Research studies are also overseen by governmental agencies, such as the Food and Drug Administration in the United States, to protect the rights and welfare of volunteers.

Once a research study begins, the IRB/EC watches over it in case there are any problems. If you are in a research study, you can contact the IRB/EC with any questions or concerns.

Study centers will follow recommended local and federal clinical guidelines.

Does participating in a research study cost me anything?

If you qualify for and agree to participate in the study, you will receive all study-related medicines and study-related care at no cost. In addition, reimbursement for study-related travel expenses may be available. 

What happens once the research study is finished?

When the research study is over, the sponsor may seek to publish the results (in a scientific journal, for example). Study results will also be posted on ClinicalTrials.gov after all study participants have completed the study and study data has been analyzed. Your identity will remain confidential. Only overall summary data results from participants will be publicly shared. Research results will never contain your name and will never publicly report your individual data.

Why did I not qualify for a research study?

Research studies are designed in specific ways to test investigational medicines for safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for the study. This does not mean you will not qualify for different research studies.

Let’s discover what’s possible together.

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Estos son los objetivos que guían el trabajo de Lilly:

Crear una estrategia sólida para los estudios de investigación clínica y llegar a poblaciones diversas:

Nuestros equipos buscan que los participantes de cada estudio reflejen la composición de la población de pacientes que podrían usar el medicamento del estudio si se lo aprueba. En los distintos estudios de todo el mundo, identificamos y abordamos los obstáculos que impiden la participación de ciertas poblaciones que normalmente tienen una representación menor.

Seleccionar intencionalmente un rango diverso de centros e investigadores:

Buscamos incorporar más investigadores y asesores externos que representen a las mujeres y las poblaciones de minorías raciales y étnicas en los estudios. Nuestro objetivo máximo es que en nuestros grupos de investigadores y asesores se refleje la composición de la población de pacientes en términos de género y raza u origen étnico.

Aumentar la representación diversa mediante asociaciones y colaboraciones:

Colaboramos con pacientes, grupos de representación de pacientes, agencias reguladoras, profesionales del cuidado de la salud y organizaciones de la comunidad para identificar e implementar soluciones que deriven en una representación diversa, que mejoren la igualdad en materia de salud y que generen pruebas para dar un mejor apoyo a los resultados de los pacientes.

Astrocitos y microglías

Mantener las neuronas en buen estado es importante para hacer cosas como moverse o para recordar cosas. Es aquí donde entran en juego los astrocitos y las microglías. Estas son células del cerebro que eliminan los desechos y protegen a las neuronas del daño físico y químico.

La enfermedad de Alzheimer distorsiona el equilibrio que mantiene a las neuronas en buen estado. Esto puede ocurrir una década o más antes de que la persona comience a tener síntomas.2

Beta amiloide y tau

La investigación sugiere que hay dos proteínas involucradas en los cambios que ocurren en el cerebro a causa de la enfermedad de Alzheimer: beta amiloide y tau.3 Por motivos que todavía se desconocen, estas proteínas se vuelven tóxicas y causan problemas en el cerebro.
  • La proteína beta amiloide se acumula en masas y forma placa. Estas placas de amiloide se acumulan entre las neuronas.
  • La proteína tau se acumula dentro de las neuronas y con el tiempo forma ovillos.
Mientras la placa de amiloide se acumula, la proteína tau se esparce rápidamente por el cerebro. Esto resulta demasiado para los astrocitos y las microglías. Como las microglías ya no pueden eliminar con eficiencia los desechos y los astrocitos quedan sometidos a situaciones de gran esfuerzo, se produce una inflamación crónica en el cerebro.4

Con el tiempo, las neuronas ya no pueden comunicarse y mueren.

Hipocampo

Cuando las neuronas mueren, el cerebro se encoge. El daño con frecuencia comienza en el hipocampo, que es responsable del aprendizaje y la memoria.2 Cuanto mayor sea la cantidad de neuronas que mueren, la persona que tiene enfermedad de Alzheimer menos podrá pensar, recordar, tomar decisiones o funcionar de manera independiente.4

Los estudios de investigación clínica están explorando opciones para detener o retrasar la aparición de problemas de memoria y pensamiento asociados a la enfermedad de Alzheimer. Si usted o un ser querido está afectado, la investigación clínica podría ofrecerles opciones.

Neuronas

Por ejemplo, consideremos qué sucede cuando mira esta imagen. Cuando miramos, gritamos, caminamos o recordamos, es el resultado de señales que se transmiten a través de los 100 000 millones de células nerviosas que tenemos en el cerebro, llamadas neuronas.

Estas neuronas se comunican entre sí mediante señales eléctricas. Estas señales pueden generar suficiente electricidad como para encender una bombilla de luz de bajo consumo.1 La combinación de estas señales eléctricas y químicas es responsable de las acciones que se mencionan anteriormente.

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YOU ARE NOW LEAVING THIS WEBSITE

You are now leaving lillyADresearch.com and being redirected to a website that is not operated by Clinical Trial Media, Inc. Please be aware, Clinical Trial Media, Inc. is not responsible for the content or availability of this website and its privacy and security policies may differ from those on this website.

Neurons

See how you’re staring at this image? When we stare, shout, walk, or remember, it’s the result of signals passing through the 100 billion nerve cells in our brain called neurons.

Electrical charges help these neurons talk to each other. These charges can generate enough electricity to power a low-wattage bulb!1 The combination of these electrical and chemical signals is responsible for the actions mentioned above.

Hippocampus

As neurons die, the brain shrinks. The damage often starts in the hippocampus, which is responsible for learning and memory.2 The more neurons die, the less a person with Alzheimer’s disease is able to think, remember, make decisions, or function independently.4

Clinical research studies are exploring ways to stop or slow down the appearance of memory and thinking problems associated with Alzheimer’s disease. If you or a loved one is affected, there may be options through clinical research.

Beta-Amyloid and Tau

Research suggests that two proteins are involved in driving changes to the brain due to Alzheimer’s disease: beta-amyloid and tau.3 For reasons still unknown, these proteins become toxic and cause problems in the brain.
  • Beta-amyloid clumps together to form plaque. These amyloid plaques build up between neurons.
  • Tau accumulates inside neurons and eventually forms tangles.
As amyloid plaque builds up, tau spreads rapidly through the brain. It’s too much for astrocytes and microglia to deal with. Because microglia are no longer able to keep up with clearing debris and astrocytes become stressed, chronic inflammation occurs within the brain.4

Eventually, neurons can no longer communicate, and they die.

Astrocytes and Microglia

Keeping the neurons healthy is important to do things like move or remember things. This is where astrocytes and microglia come in. These are cells in the brain that clear away debris and protect neurons from physical or chemical damage.

Alzheimer’s disease disrupts the balance that keeps neurons healthy. This may happen a decade or more before a person starts to show symptoms.2

These goals guide Lilly’s work:

Create a Robust Clinical Research Study Strategy and Reach Diverse Populations

Our teams aim for each study’s participants to match the composition of the patient population that might use that study’s medicine if it’s approved. Across research studies globally, we identify and address barriers that keep underrepresented populations from participating.

Intentionally Select a Diverse Range of Sites and Investigators

We aim to recruit more research study investigators and external advisors who represent women and racial/ethnic minority populations, with the ultimate goal of having our investigators and advisors match the composition of the patient population in terms of gender and race/ethnicity.

Increase Diverse Representation through Partnerships and Collaborations

We collaborate with patients, patient advocacy groups, regulatory agencies, healthcare professionals, and community organizations to identify and implement solutions that will result in diverse representation, improve health equity, and generate evidence to support better patient results.