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NCT07158905 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Institute for Molecular Medicine.

Recruiting
Registry status
Phase 1
Development phase
48
Enrollment target

NCT07158905: Recruiting Phase 1 study, sponsored by Institute for Molecular Medicine.

NCT07158905 is a Phase 1 study that is actively recruiting participants, run by Institute for Molecular Medicine. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07158905, a Phase 1 study, is actively recruiting participants, sponsored by Institute for Molecular Medicine.

RECRUITING
Registry status
Phase 1
Development phase
48 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

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

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2026-06-23
Est. Completion 2029-10-15
Phase Phase 1
Institute for Molecular Medicine

2 total trials

What NCT07158905 shows while recruiting

NCT07158905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT07158905 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07158905 about?

NCT07158905 is a clinical study titled "AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)". 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 cogniti...

What is the current status of trial NCT07158905?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2026-06-23. Estimated completion is 2029-10-15.

What interventions are being tested in trial NCT07158905?

The interventions under investigation include: Placebo (OTHER), AV-1980R 20 µg (BIOLOGICAL), AV-1980R 60 µg (BIOLOGICAL), AV-1980R 180 µg (BIOLOGICAL).

Who is sponsoring clinical trial NCT07158905?

This trial is sponsored by Institute for Molecular Medicine, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07158905's enrollment target sits among peer trials

48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07158905, the US trial registry maintained by the National Library of Medicine. NCT07158905 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.