drugset / Trial / NCT07158905
AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)
Phase 1
Recruiting
48 enrolled
Institute for Molecular Medicine
National Institute on Aging (NIA) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AV-1980R | Vaccine | 20 ug | Intramuscular |
| Subject | AV-1980R | Vaccine | 60 ug | Intramuscular |
| Subject | AV-1980R | Vaccine | 180 ug | Intramuscular |