drugset / Trial / NCT07158905

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

NCT07158905 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose-escalating trial to evaluate the safety, tolerability, and immune response of AV-1980R, an investigational vaccine targeting tau protein, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65-80 with biomarker evidence of early Alzheimer's disease will be enrolled into three ascending dose cohorts. The study is designed as a secondary prevention trial to test whether therapeutic immunization at the preclinical stage is safe, induces an immune response, and, exploratorily, may favorably affect biomarkers associated with disease progression.

Timeline

Start
2026-06-23
Primary completion
2029-06-15
Completion
2029-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject AV-1980R Vaccine 20 ug Intramuscular
Subject AV-1980R Vaccine 60 ug Intramuscular
Subject AV-1980R Vaccine 180 ug Intramuscular

Indications