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

A Phase 1 Study of the Safety and Tolerability of DUVAX, a Dual-Target Alzheimer's Vaccine (Amyloid-Beta and Tau), in Healthy Volunteers

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests the safety of DUVAX, an experimental Alzheimer's vaccine, in healthy adults ages 40–65. It checks whether the vaccine helps the body make antibodies against amyloid-beta and tau, proteins linked to Alzheimer's disease. People are assigned by chance to get DUVAX or a placebo (a shot with no vaccine) into a muscle.

This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection. The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a healthy adult age 40–65. Women must not be pregnant or breastfeeding.
  • Have a BMI of 18–32. BMI is a measure of weight compared with height.
  • Have no major health concerns on health history, exam, blood tests, heart tracing (ECG), or MRI scan.
  • Sign a form agreeing to join after learning about the study.
  • Women who can become pregnant must have a negative pregnancy test and use effective birth control.
  • Men must have had a vasectomy (surgery to prevent pregnancy), or agree to use condoms and not donate sperm during the study.

Who can't join

  • Have a major physical or mental health condition that could affect safety or study results.
  • Have certain MRI findings, such as strokes, tiny brain bleeds, or brain swelling, or be unable to safely have an MRI.
  • Have major problems on liver, kidney, or blood tests, or test positive for HIV or hepatitis B or C.
  • Have uncontrolled blood pressure, an abnormal heart rate, or a delay in the heart's electrical recovery between beats.
  • Have had a recent serious illness or surgery, or used an experimental drug within 30 days.
  • Have had treatment that uses the immune system to target amyloid-beta or tau within the past year.
  • Take drugs that weaken the immune system or use blood thinners long term.
  • Have a history of severe vaccine reactions, major allergies, or a disease in which the immune system attacks the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

FL