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NCT Number: NCT07158905

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Frontotemporal Dementia Frontotemporal Lobar Degeneration Mental Disorders Metabolic Diseases Nerve Degeneration Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Preclinical Alzheimer's Disease Proteostasis Deficiencies TDP-43 Proteinopathies Tauopathies

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Comprehensive Center for Brain Health, Boca Raton, Florida, United States

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About this study

This first-in-human study investigates AV-1980R, a MultiTEP-based active immunotherapy formulated with the adjuvant, as a secondary prevention approach for Alzheimer's disease. The study will randomize up to 48 participants aged 65-80 years in a 3:1 ratio to AV-1980R or placebo across three ascending dose cohorts (20 μg, 60 μg, 180 μg). Participants will receive four intramuscular doses at Weeks 0, 4, 12, and 36, with follow-up through Week 56.

Primary objectives are to evaluate safety and tolerability, monitored by adverse events, labs, ECGs, MRI, and neurological assessments. Secondary objectives include immunogenicity measured by anti-tau antibody titers. Exploratory endpoints include plasma biomarker and tau-PET changes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline through Week 56

    Frequency, severity, and relationship of TEAEs and SAEs; safety assessments include labs, vitals, ECGs, MRI, and neurological exams.

Secondary outcomes

  1. Number of Participants with Clinically Significant Changes in Vital Signs

    Time frame: Baseline through Week 56

    Number of participants with clinically significant abnormalities or changes in blood pressure, heart rate, respiratory rate, or body temperature.

  2. Number of Participants with Clinically Significant Changes in ECG Results

    Time frame: Baseline through Week 56

    Number of participants with new or worsening clinically significant ECG abnormalities.

  3. Number of Participants with Clinically Significant Changes in Laboratory Tests

    Time frame: Baseline through Week 56

    Number of participants with new or worsening abnormalities in hematology, serum chemistry, coagulation, or urinalysis results.

  4. Number of Participants with Clinically Significant Changes in Physical Examinations

    Time frame: Baseline through Week 56

    Number of participants with new or worsening abnormal findings on physical examination.

  5. Number of Participants with Clinically Significant Changes in Neurological Examinations

    Time frame: Baseline through Week 56

    Number of participants with new or worsening abnormal neurological findings.

  6. Incidence of Amyloid-Related Imaging Abnormalities (ARIA-E and ARIA-H)

    Time frame: Baseline through Week 56

    Number of participants with vasogenic edema (ARIA-E), effusions, ischemic events, hemorrhagic events, or associated clinical symptoms detected on MRI.

  7. Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline, Weeks 12, 36, 40, and 56

    Change from baseline in suicidality assessment using the Columbia-Suicide Severity Rating Scale (C-SSRS; range: 0-25, with higher scores indicating greater severity of suicidal ideation and behavior).

  8. Change from Baseline in Serum Anti-Tau Antibody Concentrations

    Time frame: Baseline through Week 56

    Quantification of anti-tau antibody titers induced by AV-1980R vaccination.

  9. Detection of T Helper (Th) Cell Responses Specific to MultiTEP Platform

    Time frame: Baseline through Week 56

    Presence of antigen-specific Th cell responses against the MultiTEP vaccine platform.

  10. Detection of Autoreactive Th-Cell Responses Specific to Tau

    Time frame: Baseline through Week 56

    Presence of autoreactive Th cell responses directed against tau epitopes.

Other outcomes

  1. Change from Baseline in Plasma Biomarker Concentrations (pg/mL)

    Time frame: Baseline through Week 56

    Change in plasma concentrations of Aβ42, Aβ40, pTau217, pTau181, pTau231, total tau (t-tau), neurofilament light (NfL), and glial fibrillary acidic protein (GFAP), reported in pg/mL.

  2. Change from Baseline in Immunoglobulin Isotypes and Subclasses (mg/dL)

    Time frame: Baseline through Week 56

    Change in serum concentrations of IgM, total IgG, and IgG subclasses (IgG1, IgG2, IgG3, IgG4), reported in mg/dL

  3. Phenotyping of Activated T Cells

    Time frame: Baseline through Week 56

    Characterization of activated T cell subsets by flow cytometry.

  4. T Cell Proliferative Response

    Time frame: Baseline through Week 56

    Assessment of proliferative capacity of T cells following antigen stimulation.

  5. Polarization of Cellular Responses

    Time frame: Baseline through Week 56

    Cytokine production by activated T cells to evaluate polarization of Th1/Th2/Th17 responses.

  6. Change from Baseline in Plasma Biomarker Ratios

    Time frame: Time Frame: Baseline through Week 56

    Change in plasma biomarker ratios including Aβ42/40 ratio and Aβ42/tau ratios (unitless)

Study contacts

Contact information is provided by the study sponsor or research team.

Anahit Ghochikyan

CONTACT

[email protected]

7145963981

Roman Kniazev

CONTACT

[email protected]

7145963981

Sponsors and collaborators

Lead sponsor

Institute for Molecular Medicine

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease

Acronym: TAURUS-1980

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 8, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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