Safety Evaluation of AV-1980R Tau Vaccine in Adults Aged 65 to 80 With Early Alzheimers Signs

What this Trial Is About

Researchers are studying AV-1980R, an investigational vaccine aimed at targeting pathological tau protein in adults with preclinical Alzheimers disease. This Phase 1 trial involves up to 48 cognitively healthy adults aged 65 to 80 who show biomarker evidence of this early stage of Alzheimers. The studys main goal is to evaluate the safety and tolerability of the vaccine while also assessing immune responses and exploring changes in Alzheimers disease markers and cognitive function. Participants will be assigned to one of four groups in a randomized, double-blind design three groups receive different doses of AV-1980R vaccine 20 g, 60 g, or 180 g formulated with Advax-CpG55.2 adjuvant, and one group receives a placebo with the same formulation but without the active vaccine. Each participant will receive three intramuscular injections at Weeks 0, 4, and 38. The study includes follow-up visits through Week 58 to monitor safety and immune responses. During the trial, participants will undergo regular assessments including vital signs, laboratory tests, neurological exams, MRI scans, cognitive tests, and blood tests to measure anti-tau antibodies and T-cell responses. Researchers will monitor for any treatment-emergent adverse events and serious side effects from baseline through Week 58. The total participation period spans approximately 58 weeks, during which participants are closely observed for safety and immune response changes.

AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)