Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Official Summary

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.

Eligibility Requirements

• Minimum Age: 60 Years
• Maximum Age: 85 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 1,736 participants

Study Arms

• Donanemab (EXPERIMENTAL)
  Participants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks
• Placebo (PLACEBO_COMPARATOR)
  Participants received placebo given IV.

Interventions

• DRUG: Donanemab — Given IV
• DRUG: Placebo — Given IV

Primary Outcomes

• Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population) (Baseline, Week 76)
• Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population) (Baseline, Week 76)

Secondary Outcomes

• Change From Baseline on the Mini Mental State Examination (MMSE) Score (Overall Population) (Baseline, Week 76)
• Change From Baseline on the Mini Mental State Examination (MMSE) Score (Intermediate (Low-medium) Tau Population) (Baseline, Week 76)
• Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population) (Baseline, Week 76)
• Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population) (Baseline, Week 76)
• Change From Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) (Overall Population) (Baseline, Week 76)

Eligibility Criteria

Inclusion Criteria:

* Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
* MMSE score of 20 to 28 (inclusive) at baseline
* Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
* Meet 18F florbetapir PET scan (central read) criteria
* Have a study partner who will provide written informed consent to participate

Exclusion Criteria:

* Contraindication to MRI or PET scans
* Current treatment with immunoglobulin G (IgG) therapy

Trial Locations

• Gilbert Neurology, Gilbert, Arizona, United States
• Xenoscience, Phoenix, Arizona, United States
• Banner Alzheimer's Institute, Phoenix, Arizona, United States
• Perseverance Research Center, Scottsdale, Arizona, United States
• Banner Sun Health Research Institute, Sun City, Arizona, United States
• Banner Alzheimer's Institute Tucson, Tucson, Arizona, United States
• Center for Neurosciences, Tucson, Arizona, United States
• Health Initiatives Research, Fayetteville, Arkansas, United States
• North County Neurology Associates, Carlsbad, California, United States
• Wr- Pri, Llc, Encino, California, United States
• ...and 10 more locations

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) — STUDY_DIRECTOR
  Eli Lilly and Company

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