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AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)
Sponsor: Institute for Molecular Medicine
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.
Official title: A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease
Key Details
Gender
All
Age Range
65 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-06-23
Completion Date
2029-10-15
Last Updated
2026-06-26
Healthy Volunteers
No
Interventions
AV-1980R 20 µg
MultiTEP-based investigational tau vaccine formulated with the adjuvant. The vaccine is designed to elicit anti-tau antibodies in participants with preclinical Alzheimer's disease.
AV-1980R 60 µg
MultiTEP-based tau vaccine formulated with the adjuvant, 60 µg per dose; intramuscular injections at Weeks 0, 4, 12, and 36; secondary-prevention immunotherapy in preclinical AD.
AV-1980R 180 µg
MultiTEP-based tau vaccine formulated with the adjuvant, 180 µg per dose; intramuscular injections at Weeks 0, 4, 12, and 36; secondary-prevention immunotherapy in preclinical AD.
Placebo
10 mM phosphate buffer formulated with the adjuvant; intramuscular injections at Weeks 0, 4, 12, and 36; no active antigen.
Locations (3)
Comprehensive Center for Brain Health
Boca Raton, Florida, United States
Alzheimer's Research and Treatment Center (Stuart)
Stuart, Florida, United States
Alzheimer's Research and Treatment Center (Wellington)
Wellington, Florida, United States