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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
2025-12-15
Completion Date
2029-10-15
Last Updated
2025-09-08
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 (1)
Comprehensive Center for Brain Health
Boca Raton, Florida, United States