AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)
United States48 participantsStarted 2026-06-23
Plain-language 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.
Who can participate
Age range
65 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Male or postmenopausal or surgically sterile female, 65 to 80 years of age, inclusive.
Cognitively unimpaired participant with preclinical Alzheimer's disease who meets all of the following:
Clinical Dementia Rating global score of 0 at Screening. Mini-Mental State Examination score ≥26, with education adjustment at Screening.
Plasma p-tau217/Aβ42 ratio ≥0.00738 measured using Lumipulse (Fujirebio). A prior positive result obtained within 12 months before Screening may be accepted but must be confirmed by the central laboratory.
Sight and hearing, including use of a hearing aid, sufficient to comply with study procedures.
Stable concomitant medications. Participants receiving fluctuating medication or treatment may be considered if the underlying condition is controlled.
Signed informed consent before any study-related procedure. Ability, in the Investigator's opinion, to understand the study and comply with protocol requirements.
Exclusion Criteria:
Screening MRI showing any of the following:
More than one noncortical lacunar infarct greater than 1.5 cm. Any territorial infarct greater than 1.5 cm. Combined microbleeds and areas of leptomeningeal hemosiderosis greater than 5, or disseminated leptomeningeal hemosiderosis.
Any other significant cerebral abnormality, including ARIA-E. Contraindication to MRI, including non-MRI-safe implanted metallic devices or clinically significant claustrophobia.
Serious illness requiring systemic treatment or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily focused on safety, what does that mean for what we can and can't expect to learn about whether AV-1980R actually slows or prevents Alzheimer's — and how does that affect whether it might be right for me?
2The trial is targeting people with preclinical Alzheimer's disease, meaning no symptoms yet — how would you determine if I'm actually at the right stage to even be considered for something like this?
3Because this is a tau vaccine and tau is just one of several proteins involved in Alzheimer's, is there anything about my specific situation that would make targeting tau more or less relevant compared to other approaches?
4Since the main thing being measured is adverse events and serious adverse events, what kinds of side effects or immune responses are typically a concern with vaccine-based approaches like this, and what should I watch out for if I were to participate?
5Given that this is an early-phase trial for preclinical disease, are there any standard monitoring strategies or other clinical options I should be pursuing alongside or instead of exploring this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events