A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease

Lilly

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease (AD)

Treatments: Drug: Zagotenemab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03518073

16124

I8G-MC-LMDC (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 360 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received intravenous (IV) infusion of placebo once every four weeks (Q4W) for 100 weeks.

Treatment:

Drug: Placebo

Zagotenemab 1400 mg

Experimental group

Description:

Participants received IV infusion of 1400 milligram (mg) zagotenemab Q4W for 100 weeks.

Treatment:

Drug: Zagotenemab

Zagotenemab 5600 mg

Experimental group

Description:

Participants received IV infusion of 5600 mg zagotenemab Q4W for 100 weeks.

Treatment:

Drug: Zagotenemab