Assessment of Safety, Tolerability, and Efficacy of LY3303560 in Early Symptomatic Alzheimer's Disease
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Alzheimer Disease (AD)
- Sponsor
- Eli Lilly and Company
- Enrollment
- 360
- Locations
- 57
- Primary Endpoint
- Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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).
Investigators
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
Arms & Interventions
Placebo
Participants received intravenous (IV) infusion of placebo once every four weeks (Q4W) for 100 weeks.
Intervention: Placebo
Zagotenemab 1400 mg
Participants received IV infusion of 1400 milligram (mg) zagotenemab Q4W for 100 weeks.
Intervention: Zagotenemab
Zagotenemab 5600 mg
Participants received IV infusion of 5600 mg zagotenemab Q4W for 100 weeks.
Intervention: Zagotenemab
Outcomes
Primary Outcomes
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Time Frame: Baseline, Week 104
Integrated Alzheimer's Disease Rating Scale (iADRS) is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether zagotenemab slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval.
Secondary Outcomes
- Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score(Baseline, Week 104)
- Change From Baseline on the Mini Mental Status Examination (MMSE) Score(Baseline, Week 104)
- Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)(Baseline, Week 104)
- Change From Baseline on the Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score(Baseline, Week 104)
- Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score(Baseline, Week 104)
- Change From Baseline in Brain Aggregated Tau Deposition as Measured by Flortaucipir F-18 Positron Emission Tomography (PET) Scan.(Baseline, Week 104)
- Number of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline through Week 104)
- Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Zagotenemab(Baseline through Week 113)