A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Conditions

• Alzheimer's Disease
• Brain Diseases
• Central Nervous System Diseases
• Dementia
• Mental Disorders
• Nervous System Diseases
• Neurocognitive Disorders
• Neurodegenerative Diseases

Eligibility Criteria

Sex

ALL

Age

60 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Donanemab — DRUG
  Administered IV
• Placebo — DRUG
  Administered IV
• Dexamethasone — DRUG
  Administered IV

Study Details

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled in addendum 2. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study.

Key Dates

First listed

Feb 22, 2023

Start date

Feb 28, 2023

Status verified

Oct 2025

Primary completion

May 16, 2024

Completion

May 31, 2027

Study Design

Enrollment

1,175 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1400 mg Donanemab - Standard Regimen
  Participants received: * 700 milligrams (mg) donanemab administered intravenously (IV) at baseline, week 4, and 8. * placebo administered IV at week 2, 6, 10, and 14. * 1400 mg of donanemab administered IV at week 12, 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose
• Experimental: 1400 mg Donanemab - Dose Skipping
  Participants received: * 700 mg donanemab administered IV at baseline. * placebo administered IV at week 2, 4, 6, 10, and 14. * 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose
• Experimental: 1400 mg Donanemab - Titration
  Participants received: * 350 mg donanemab administered IV at baseline. * placebo administered IV at week 2, 6, 10, and 14. * 700 mg donanemab administered IV at week 4. * 1050 mg of donanemab administered IV at week 8. * 1400 mg of donanemab administered IV at week 12, 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose
• Experimental: 1400 mg Donanemab - Maximum Concentration (Cmax)
  Participants received: * 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10. * 700 mg donanemab administered IV at weeks 12 and 14. * 1400 mg of donanemab administered IV at weeks 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose
• Experimental: Donanemab Addendum 2 Arm 1
  Participants will receive donanemab by IV infusion. Participants will receive placebo pretreatment to preserve the blind prior to donanemab infusion.
• Experimental: Donanemab Addendum 2 Arm 2
  Participants will receive donanemab by IV infusion. Participants will receive dexamethasone pretreatment prior to donanemab infusion

Primary Outcome Measure

Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E) [ Time Frame: 24 Weeks ]

Locations (43)

Related coverage on Hipa.ai

• Donanemab Titration Regimen Reduces ARIA-E in Early Alzheimer's Disease
  Donanemab · Nov 14, 2025 · ClinicalTrials.gov

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