NCT07158905 · Phase 1 · NOT YET RECRUITING
AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)
This trial is testing AV-1980R, an experimental vaccine designed to trigger the immune system against tau — the protein that forms tangles in Alzheimer's-affected brains. It enrolls cognitively normal adults aged 65-80 who already show early Alzheimer's biomarkers in their blood. The goal right now is safety and immune response, not proof that it works. This is a Phase 1 trial — the earliest stage, focused on whether the vaccine is safe in humans.
Eligibility criteria
Inclusion Criteria: Male or post-menopausal/surgically sterile female, 65-80 years of age. Cognitively unimpaired with preclinical Alzheimer's disease: CDR global score = 0. MMSE ≥ 26. WMS-R LM II ≥ 6. Amyloid Probability Score 2 (APS2) > 54 (PrecivityAD2™). Adequate vision/hearing to comply with study procedures. Stable concomitant medications if applicable. Signed informed consent. Exclusion Criteria: MRI abnormalities: >1 large lacunar infarct, territorial infarct, >5 microbleeds, ARIA-E, or other significant pathology. Contraindications to MRI (e.g., pacemaker, metallic implants, severe claustrophobia). Serious illness or hospitalization within 4 weeks prior to enrollment. Clinically significant cardiovascular, endocrine, hematologic, autoimmune, or neurological disease. Insulin-dependent diabetes, significant arrhythmias, or seizure disorder. Positive C-SSRS (score ≥ 3). Prior tau or amyloid-beta immunotherapy within 1 year. Immunosuppressive or anticoagulant use that could interfere with study safety. Clinically significant lab abnormalities or positive HIV, HBV, or HCV screening.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-05-22