RecruitingAlzheimer DiseasePreclinical Alzheimer's Disease
AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)
Eligible age
65–80 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Institute for Molecular Medicine
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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 hospitalization within 4 weeks before study entry.
- ✕ Clinically relevant cardiovascular, respiratory, gastrointestinal, endocrine, immunologic, hematologic, systemic disease, or major surgery that could interfere with participation or follow-up.
- ✕ Insulin-dependent diabetes. Clinically relevant cardiac arrhythmia, palpitation, conduction abnormality, prolonged QT interval, or bundle branch block.
- ✕ Pre-existing autoimmune disease. C-SSRS score of 3 or higher. History of seizure disorder, except permitted stable use of certain antiepileptic medications for chronic pain.
- ✕ Any medical, psychological, or social condition that could interfere with participation, compliance, or participant safety.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07158905 · last updated 2026-08-04