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

This study is testing an investigational vaccine called AV-1980R in people with preclinical Alzheimer's disease. This means you would have early signs of Alzheimer's in your body, but no memory or thinking problems. The vaccine aims to help your body create antibodies against a protein called tau, which is linked to Alzheimer's. Researchers want to see if AV-1980R is safe, how well people tolerate it, and if it creates an immune response. Up to 48 adults, aged 65-80, who are cognitively unimpaired but have specific biomarker evidence of early Alzheimer's (like a high Amyloid Probability Score 2 or APS2) can participate. Success in this study means showing the vaccine is safe and triggers an immune response. The current recruitment status is unclear.

Study design
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled study with up to 48 participants. Participants will be assigned to receive AV-1980R at different doses or a placebo.
What's involved
Participants will receive four intramuscular injections at Weeks 0, 4, 12, and 36. Safety will be monitored through adverse events, lab tests, ECGs, MRI, and neurological assessments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through Week 56 after their first dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07158905

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

Recruiting
PHASE1Ages 65–80InterventionalPrevention
Institute for Molecular Medicine
~48 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:AV-1980R 20 µgAV-1980R 60 µgAV-1980R 180 µgPlacebo

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events
Measured over Baseline through Week 58
Alzheimer Disease
Preclinical Alzheimer's Disease
6 sites across 2 states
Florida5
Georgia1
  • Michael Agadjanyan, PhD · PRINCIPAL_INVESTIGATOR · Institute MM
  • Roman Kniazev · STUDY_DIRECTOR · Institute MM

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  • Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse EventsBaseline through Week 58

    Number of participants who experience one or more treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs), summarized by severity and relationship to study intervention.