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LY3303560 Infusions for in Early Symptomatic Alzheimer’s Disease


Title Assessment of Safety, Tolerability, and Efficacy of LY3303560 in Early Symptomatic Alzheimer’s Disease
Therapeutic Area Alzheimer's Disease
Principal Investigator Tinatin Chabrashvilil, MD, PhD
Min Age 60 Years
Max Age 85 Years
Gender All
Contact Sarah Gans
617-636-7606
More Information https://clinicaltrials.gov/ct2/show/NCT03518073

Overview

This study involves repeated doses of LY3303560 given by IV infusion every month for 80 weeks. LY3303560 is a substance called an antibody. It targets Tau, which is a protein in the brain that builds up during the progression of Alzheimers’s disease. This study will examine how safe repeated doses of LY3303560 are (when compared to a placebo), its impact on the cognitive progression of participants with early symptomatic Alzheimer's Disease, and how LY3303560 is handled by the body and acts in the body. 

Study Details

Inclusion Criteria

  • Gradual and progressive change in memory function reported by patient or informant for 6 months or more
  • Presence of a study partner who has frequent contact with patient (defined as more than 10 hours per week)

Exclusion Criteria

  • Current Neruological or Psychiatric diagnosis other than AD that could affect cognition
  • History of alcohol or drug disorder use (except tobacco) within 2 years
  • Inability or unwillingness to undergo MRI scannings

Study Requirements

You will first be screened to make sure you are eligible to participate in the study.  The screening period can last up to 8 weeks and includes a PET scan and MRI scan as well.  After screening, you will be randomly assigned to 1 of 3 treatment groups: either study drug (1400mg, 5600mg), or placebo (liquid in a syringe that has a similar appearance to the study drug, but has no medicine). The study drug will be given through an intravenous (IV) line, every 4 weeks for 76 weeks. These study visits will last approximately 2 hours and include physical exams, blood draws, and cognitive assessments and surveys. Through the course of the study, you will have 2 PET scans and 2 MRI scans.