NCT07158905

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

A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Institute for Molecular Medicine · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This first-in-human study investigates AV-1980R, a MultiTEP-based active immunotherapy formulated with the adjuvant, as a secondary prevention approach for Alzheimer's disease. The study will randomize up to 48 participants aged 65-80 years in a 3:1 ratio to AV-1980R or placebo across three ascending dose cohorts (20 μg, 60 μg, 180 μg). Participants will receive four intramuscular doses at Weeks 0, 4, 12, and 36, with follow-up through Week 56. Primary objectives are to evaluate safety and tolerability, monitored by adverse events, labs, ECGs, MRI, and neurological assessments. Secondary objectives include immunogenicity measured by anti-tau antibody titers. Exploratory endpoints include plasma biomarker and tau-PET changes.

Conditions

• Alzheimer Disease
• Preclinical Alzheimer's Disease

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	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.
BIOLOGICAL	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.
OTHER	Placebo	10 mM phosphate buffer formulated with the adjuvant; intramuscular injections at Weeks 0, 4, 12, and 36; no active antigen.

Timeline

• Start date: 2025-12-15
• Primary completion: 2029-06-15
• Completion: 2029-10-15
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study