Phase 2
Completed N=272
A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
Source: ClinicalTrials.gov NCT03367403 ↗Enrolled (actual)
272
Serious AEs
19.9%
Results posted
Feb 2022
Primary outcomePrimary: Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score — -6.86; -10.06 score on a scale — p=0.042
Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score |
-6.86; -10.06 | 0.042 sig |
| SECONDARY Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score |
2.91; 4.77 | 0.040 sig |
| SECONDARY Change From Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score |
1.22; 1.58 | 0.139 |
| SECONDARY Change From Baseline in the Mini Mental State Examination (MMSE) Score |
-2.35; -2.98 | 0.227 |
| SECONDARY Change From Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score |
-3.98; -5.20 | 0.230 |
| SECONDARY Change From Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan |
-84.13; 0.93 | <0.001 sig |
| SECONDARY Change From Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan |
0.55; 0.55; 1.54; 1.58 | 0.560 |
| SECONDARY Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI) |
-11.18; -8.51; -0.17; -0.17; -0.22; -0.22 | < 0.001 sig |
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 or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.
- Meet 18F flortaucipir PET scan eligibility criteria.
- Meet 18F florbetapir PET scan (central read) eligibility criteria.
Exclusion Criteria
- Have a history of long QT syndrome.
- Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.
- Contraindication to MRI.
Data sourced from ClinicalTrials.gov (NCT03367403). 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.