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

NCT07158905

RecruitingPhase 1

Sponsor: Institute for Molecular Medicine

Conditions: Alzheimer Disease, Preclinical Alzheimer's Disease

Interventions: AV-1980R 20 µg, AV-1980R 60 µg, AV-1980R 180 µg, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 65 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (5)
  • Boca Raton, Florida, United States
  • Miami Lakes, Florida, United States
  • Stuart, Florida, United States
  • Tampa, Florida, United States
  • Wellington, Florida, United States