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

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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

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

Trial documents
2

Trial contacts and locations

60

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Data sourced from clinicaltrials.gov

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