Early Symptomatic Alzheimer’s Disease Trial of LY3303560

  • Study Director: Julio Rojas-Martinez, MD, PhD
  • Sponsor: Eli Lilly and Company
  • Status: Active, but no longer recruiting
  • Official Study Title: A Study of LY3303560 in Participants with Early Symptomatic Alzheimer’s Disease
  • ClinicalTrials.gov Identifier: NCT03518073
  • Conditions Studied: Alzheimer’s disease (AD)
  • Intervention: LY3303560 and placebo control
  • Phase: Phase 2
  • Duration of Participation: 80 weeks

Purpose of the Study

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.


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.

What to Expect

Testing: Neurological and physical examinations, MRIs, PET scans, cognitive testing and neuropsychiatric assessments, ECGs, blood and urine specimen collection, and vital signs

The Frequency of Visits:

  • Screening phase: up to 8 weeks
  • Dose administration in placebo-controlled period: every 4 weeks for 76 weeks
  • Follow up visits after dose administration period: 4 weeks after last dose and safety follow-up period of up to 52 weeks

Materials Needed Before Evaluation: Prior to participating in the trial, the patient will need a confirmed diagnosis of mild cognitive impairment (MCI) or Alzheimer’s disease.

Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits. Participants will be reimbursed up to $200 for each scheduled visit to help defray any incidental expenses incurred in the course of participating in this study.

Contact Information

Coordinator: Hannah Wiest[email protected], 415.476.0671
Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRC[email protected], 415.476.0661