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

NCT07158905 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-08-21

No results posted yet for this study

Summary

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple-dose-escalation study evaluating the safety, tolerability, and immunogenicity of AV-1980R, an investigational vaccine targeting pathological tau, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65 to 80 years with biomarker evidence of preclinical Alzheimer's disease will be enrolled into three ascending-dose cohorts.

Conditions

Interventions

BIOLOGICAL

AV-1980R 20 µg

AV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 20 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.

BIOLOGICAL

AV-1980R 60 µg

AV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 60 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.

BIOLOGICAL

AV-1980R 180 µg

AV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 180 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.

OTHER

Placebo

The placebo consists of 10 mM phosphate buffer without active AV-1980R, formulated with Advax-CpG55.2, consisting of Advax and CpG55.2. It is administered by intramuscular injection at Weeks 0, 4, and 38.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Institute for Molecular Medicine

    lead OTHER

Principal Investigators

  • Michael Agadjanyan, PhD · Institute MM

  • Roman Kniazev · Institute MM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-23
Primary Completion
2029-06-15
Completion
2029-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07158905 on ClinicalTrials.gov