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Alzheimer's DiseaseAugust 2023

What the TRAILBLAZER-ALZ 2 Trial Found — Donanemab for Early Alzheimer's

TRAILBLAZER-ALZ 2 tested donanemab, a monthly IV antibody that targets amyloid plaques in the brain, in 1,736 people with early symptomatic Alzheimer's. After 76 weeks, donanemab slowed cognitive decline most in people whose disease was caught earliest.

What the trial was testing

The TRAILBLAZER-ALZ 2 enrolled 1,736 patients with alzheimer's disease. The study was sponsored by Eli Lilly and tracked outcomes across the full group of patients who matched the trial's eligibility profile.

It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.

What the results showed

35% slower decline — with the largest benefit in people caught soonest.

JAMA · 2023 · NCT04437511

These findings — that in cognitive and daily function for people with early Alzheimer's, especially those caught soonest — were published in the JAMA and represent the headline result of the study.

Researchers tracked outcomes across 1,736 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.

What this means for patients

For patients with alzheimer's disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.

What you can do now

Donanemab (Kisunla) is FDA-approved and available now. Treatment can stop once amyloid is cleared from the brain, which often happens within 12 to 18 months. Brain swelling and small bleeds are real risks, so most centers screen for the APOE4 gene before starting. Ask a neurologist about eligibility.

Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.