About the TRAILBLAZER-ALZ 3 Addendum 7 Study

The TRAILBLAZER-ALZ 3 Addendum 7 Study is comparing the safety and side effects of 2 different dosing schedules of an investigational medicine for people who have normal memory and thinking, but who are at risk for developing Alzheimer's disease symptoms.

You may be able to take part in this study if you:

Are aged 65 to 80 years old
Have normal memory, thinking, mood and behavior patterns
Meet additional study requirements

*A study partner is a person who knows you well and would notice any changes in your memory, mood, or behavior. This could be your spouse, partner, friend, family member, or someone whose job it is to help you. Your study partner would also need to consent to participate in the research study.

If you are interested in participating, the study doctor and staff will review additional eligibility criteria with you.

Study Overview

If you qualify to take part in the TRAILBLAZER-ALZ 3 Addendum 7 Study, you will be randomly (that is by chance) assigned to 1 of 2 dosing schedules of the investigational medicine, with a 50/50 chance of being placed in either group. The investigational medicine will be given as intravenous (IV) infusions.

Participant duration will last approximately 1 year.

During the study you will attend visits with doctors and researchers in-person at a clinic and by phone. The study involves people who have normal memory, thinking, mood and behavior patterns.

Let’s discover what’s possible together.

See If You May Qualify

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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.

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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.

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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.

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Sources

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3424456/

2 https://s3-eu-west-1.amazonaws.com/wof-files/World_Obesity_Atlas_2023_Report.pdf

3 https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)

4 https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure

5 https://www.cdc.gov/heart-disease/risk-factors/index.html

6 https://www.nhlbi.nih.gov/health/sleep-apnea

7 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4561280/

8 https://pubmed.ncbi.nlm.nih.gov/37202064/

9 https://www.cdc.gov/arthritis/types/osteoarthritis.htm

10 https://onlinelibrary.wiley.com/doi/10.1002/art.42089

11 https://www.hopkinsarthritis.org/patient-corner/disease-management/role-of-body-weight-in-osteoarthritis/

12 https://www.who.int/news-room/fact-sheets/detail/diabetes

13 https://www.cdc.gov/diabetes/risk-factors/?CDC_AAref_Val=https://www.cdc.gov/diabetes/basics/risk-factors.html

14 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874486

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

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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.