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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65-80
SponsorInstitute for Molecular Medicine

About this trial

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 criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • AV-1980R 20 µg
  • AV-1980R 60 µg
  • AV-1980R 180 µg
  • Placebo

Treatment groups

48 Participants
are divided into 4 treatment groups

Locations

3
Comprehensive Center for Brain Health33433, Boca RatonFlorida, United States
Alzheimer's Research and Treatment Center (Stuart)34996, StuartFlorida, United States
Alzheimer's Research and Treatment Center (Wellington)33414, WellingtonFlorida, United States

Sponsors and collaborators

Institute for Molecular Medicine

Lead sponsor

National Institute on Aging (NIA)

Collaborator