- 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.
Eligibility
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