Phase 2
N=360
A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease (AD)
Bottom Line
View on ClinicalTrials.gov: NCT03518073 ↗Enrolled (actual)
360
Serious AEs
15.3%
Results posted
Aug 2022
Primary outcome: Primary: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) — -13.72; -15.11; -14.38 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Zagotenemab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) |
-13.72; -15.11; -14.38 | — |
| SECONDARY Change From Baseline on the Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score |
7.13; 7.85; 6.30 | — |
| SECONDARY Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score |
-6.67; -7.06; -8.05 | — |
| SECONDARY Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score |
2.26; 2.52; 2.14 | — |
| SECONDARY Change From Baseline on the Mini Mental Status Examination (MMSE) Score |
-4.29; -4.44; -3.83 | — |
| SECONDARY Change From Baseline in Brain Aggregated Tau Deposition as Measured by Flortaucipir F-18 Positron Emission Tomography (PET) Scan. |
0.08; 0.10; 0.10 | 0.253 |
| SECONDARY Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI) |
-24.06; -23.44; -23.55 | 0.691 |
| SECONDARY Number of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) |
5; 5; 5; 1; 2; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Zagotenemab |
2; 1 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of a study drug that targets an abnormal protein in the brain found in people with Alzheimer's Disease (AD).
Eligibility Criteria
Inclusion Criteria
- Participants must have gradual and progressive change in memory function for >6 months.
- Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments.
Exclusion Criteria
- Participants must not have significant neurological disease affecting the nervous system, other than AD, that affects cognition or may affect completion of the study.
- Participants must not have serious or unstable illness that could interfere with the analysis of the study or has a life expectancy <24 months.
- Participants must not have history of cancer within the last 5 years with the exception of certain types of skin, cervical, prostate, and other cancers that are not likely to recur or spread.
- Participants must not have serious risk for suicide.
- Participants must not have history of drug or alcohol use disorder within the last 2 years.
- Participants must not have multiple severe drug allergies
- Participants must not have HIV, Hepatitis B or Hepatitis C
- Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin (IVIG) therapy
Data sourced from ClinicalTrials.gov (NCT03518073). 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.