This is a 5 year, Phase 3, randomized, placebo-controlled, double-blind study enrolling approximately 1200 participants worldwide. This study involves an investigational medication, Remternetug, which is an IgG1 monoclonal antibody targeting amyloid protein.
Eligible participants will be randomly assigned to one of two groups, one which receives the investigational medication and one that receives placebo. A placebo is an inactive substance that is designed to look like a medication. The investigational medication or the placebo will be administered by subcutaneous injection. The treatment phase of the study will last about 18 months, with an additional observation period to follow.
People with early Alzheimer’s disease (AD) may not have symptoms and may not have been diagnosed with Alzheimer’s disease. People with early AD may have an abnormal amount of amyloid protein in the brain that could increase the risk of developing memory and thinking problems in the future. If you participate in this study, you will have a blood test to check if you have this abnormal level of amyloid protein in your brain.
The purpose of the TRAILRUNNER ALZ-3 Study is to evaluate the safety and efficacy of Remternetug in participants with early Alzheimer’s disease, and to learn whether Remternetug can delay the start or worsening of memory and thinking problems caused by AD.
The participants in this study must be between the ages of 65-80 with either no symptoms of Alzheimer’s disease or with mild cognitive impairment. Participants must have a study partner, who has at least weekly contact with them, who can accompany them to some study visits.
Interested participants can contact the Memory and Aging Program Outreach Team at (401) 455-6402 or by sending an email to memory@butler.org to discuss additional eligibility criteria.