NCT07142278 · Phase 1 · NOT YET RECRUITING

DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau

DUVAX is an experimental vaccine designed to trigger the immune system to produce antibodies against amyloid-beta and tau, two proteins that build up in Alzheimer's disease. This Phase 1 trial is the earliest stage of human testing — focused on safety and immune response, not yet on whether it slows or prevents disease. Researchers are comparing two doses against a placebo in healthy adults ages 40 to 65.

You may qualify if

  • Healthy males and non-pregnant, non-lactating females, 40-65 years old
  • BMI between 18.0 and 32.0 kg/m²
  • Medically healthy with no significant abnormalities in medical history, exam, labs, ECG, or MRI
  • Signed informed consent
  • Women of childbearing potential: negative pregnancy test and use of effective contraception
  • Men: vasectomized or agree to use condoms / not donate sperm during the study period

You're excluded if

  • Clinically significant medical or psychiatric illness that may affect safety or study results
  • MRI abnormalities (e.g., infarcts, microbleeds, ARIA-E) or contraindications to MRI
  • Significant lab abnormalities (e.g., liver, kidney, hematology) or positive HIV/HBV/HCV tests
  • Uncontrolled blood pressure, abnormal heart rate, or prolonged QTc interval
  • Recent serious illness, surgery, or investigational drug use within 30 days
  • Prior amyloid-beta or tau immunotherapy within 1 year
  • Use of immunosuppressive agents or chronic anticoagulants
  • History of severe vaccine reactions, autoimmune disease, or significant allergies

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 2025-10-22

View full record on ClinicalTrials.gov

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