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

Conditions

• Alzheimer Disease
• Preclinical Alzheimer's Disease

Eligibility Criteria

Sex

ALL

Age

65 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• AV-1980R 20 µg — BIOLOGICAL
  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.
• AV-1980R 60 µg — BIOLOGICAL
  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.
• AV-1980R 180 µg — BIOLOGICAL
  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.
• Placebo — OTHER
  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.

Study Details

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.

Key Dates

First listed

Sep 8, 2025

Start date

Jun 23, 2026

Status verified

Jul 2026

Primary completion

Jun 15, 2029

Completion

Oct 15, 2029

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: AV-1980R 20 µg Arm
  Participants receive 20 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.
• Experimental: AV-1980R 60 µg Arm
  Participants receive 60 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.
• Experimental: AV-1980R 180 µg Arm
  Participants receive 180 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.
• Placebo Comparator: Placebo Arm
  Participants receive 10 mM phosphate buffer without active AV-1980R, formulated with Advax-CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.

Primary Outcome Measure

Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events [ Time Frame: Baseline through Week 58 ]

Central Contacts

• Roman Kniazev
  7145963981
  [email protected]
• Anahit Ghochikyan
  7145963981
  [email protected]

Locations (6)

Find similar trials in Boca Raton, FL

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