Phase 2
Completed N=95
A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)
Alzheimer's Disease · Dementia · Brain Diseases · Central Nervous System Diseases
Source: ClinicalTrials.gov NCT04640077 ↗
Enrolled (actual)
95
Serious AEs
11.3%
Results posted
Jun 2025
Primary outcomePrimary: Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments — 0.8172; 0.8819; 0.8251; 0.8254 Intraclass correlation coefficient
Summary
The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate neuropsychological assessments administered over videoconferencing
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments |
0.8172; 0.8819; 0.8251; 0.8254 | — |
| PRIMARY Part B: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
90.9; 29.1 | — |
| PRIMARY Part B: Number of Participants With Suicidality Based on Columbia-Suicide Severity Rating Scale (C-SSRS) |
3; 1 | — |
| SECONDARY Part B: Change From Baseline on the Mini Mental State Examination (MMSE) Score |
-0.87 | — |
| SECONDARY Part B: Change From Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score |
4.63 | — |
| SECONDARY Part B: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) |
-10.14 | — |
| SECONDARY Part B: Change From Baseline on the Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living (ADCS-iADL) |
-6.21 | — |
| SECONDARY Part B: Change From Baseline on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) |
1.87 | — |
| SECONDARY Part B: Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan |
-80.1 | — |
| SECONDARY Part B: Change From Baseline in Whole Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI) |
-27.75 | — |
| SECONDARY Part B: Pharmacokinetics (PK): Trough Concentrations of Donanemab (Ctrough) |
5.62; 6.64 | — |
| SECONDARY Part B: Number or Participants With Treatment-Emergent Anti-Drug Antibodies (TE ADA) of Donanemab |
38 | — |
Eligibility Criteria
Inclusion Criteria
- Participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the TRAILBLAZER-ALZ study.
- Have a study partner
- Stable symptomatic Alzheimer's Disease (AD) medications and other medication that may impact cognition for at least 30 days prior to randomization into Part A
Exclusion Criteria
- Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with outcome assessments or the analyses in this study.
- Have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against Aβ in any other study.
- Poor venous access
- Contraindication to PET or MRI imaging
Data sourced from ClinicalTrials.gov (NCT04640077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.