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TRAILBLAZER-EXT: Donanemab Follow-On Study in Alzheimer's Disease
NCT04640077Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2020
- Primary completion
- Feb 2024
- Countries
- 2
- Sponsor
- Eli Lilly and Company
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- donanemab
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 2, randomised, open-label trial of donanemab in Alzheimer's disease (AD) (2 arms), sponsored by Eli Lilly and Company. Primary endpoints: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments at 4 weeks, Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) at 96 weeks and 1 more. Started Nov 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Validation Cohort
Participants undergo cognitive assessments via VTC and On-site for validation. No intervention.
Donanemab Extension
Participants from originating trials (placebo arm) receive Donanemab.
03
Who it enrols
Participants must have completed a sponsor-approved originating donanemab trial (e.g., TRAILBLAZER-ALZ) and have stable symptomatic AD medications. Exclusion criteria include serious unstable illnesses or prior treatment with other anti-amyloid immunotherapies.
04
Endpoints
Primary
Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments
Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of Participants With Suicidality Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Secondary
Change From Baseline on the Mini Mental State Examination (MMSE) Score
Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL)
Change From Baseline on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan
Change From Baseline in Whole Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
Pharmacokinetics (PK): Trough Concentrations of Donanemab (Ctrough)
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