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

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
Institute for Molecular Medicine
Study ID
NCT07158905
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AV-1980R 20 µg — BIOLOGICAL
    MultiTEP-based investigational tau vaccine formulated with the adjuvant. The vaccine is designed to elicit anti-tau antibodies in participants with preclinical Alzheimer's disease.
  • AV-1980R 60 µg — BIOLOGICAL
    MultiTEP-based tau vaccine formulated with the adjuvant, 60 µg per dose; intramuscular injections at Weeks 0, 4, 12, and 36; secondary-prevention immunotherapy in preclinical AD.
  • AV-1980R 180 µg — BIOLOGICAL
    MultiTEP-based tau vaccine formulated with the adjuvant, 180 µg per dose; intramuscular injections at Weeks 0, 4, 12, and 36; secondary-prevention immunotherapy in preclinical AD.
  • Placebo — OTHER
    10 mM phosphate buffer formulated with the adjuvant; intramuscular injections at Weeks 0, 4, 12, and 36; no active antigen.

Study Details

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.

Key Dates

Start date
Aug 3, 2026
Status verified
Aug 2025
Primary completion
Jun 15, 2029
Completion
Oct 15, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: AV-1980R 20 µg Arm
    Participants receive 20 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.
  • Experimental: AV-1980R 60 µg Arm
    Participants receive 60 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.
  • Experimental: AV-1980R 180 µg Arm
    Participants receive 180 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.
  • Placebo Comparator: Placebo Arm
    Participants receive placebo injections (10 mM phosphate buffer with the adjuvant, no antigen) at Weeks 0, 4, 12, and 36.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline through Week 56 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Comprehensive Center for Brain HealthBoca RatonFlorida33433
Magdalena Dr. Tolea, PhD, MS, MA

Find similar trials in Boca Raton, FL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Comprehensive Center for Brain Health· Boca Raton, FL

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