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

NCT07158905 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IMM-AV1980R-1021R01AG092949-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Preclinical Alzheimer's Disease

Keywords

Tau protein; Immunotherapy; Vaccine; Preclinical Alzheimer's Disease; Alzheimer's Disease; secondary prevention; Neurodegeneration; Preventive Alzheimer's

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline through Week 56

Secondary Outcomes (10)

• Number of Participants with Clinically Significant Changes in Vital Signs

  Baseline through Week 56

• Number of Participants with Clinically Significant Changes in ECG Results

  Baseline through Week 56

• Number of Participants with Clinically Significant Changes in Laboratory Tests

  Baseline through Week 56

• Number of Participants with Clinically Significant Changes in Physical Examinations

  Baseline through Week 56

• Number of Participants with Clinically Significant Changes in Neurological Examinations

  Baseline through Week 56

Other Outcomes (6)

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

  Baseline through Week 56

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

  Baseline through Week 56

• Phenotyping of Activated T Cells

  Baseline through Week 56

Study Arms (4)

AV-1980R 20 µg Arm

EXPERIMENTAL

Participants receive 20 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.

Biological: AV-1980R 20 µg

AV-1980R 60 µg Arm

EXPERIMENTAL

Participants receive 60 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.

Biological: AV-1980R 60 µg

AV-1980R 180 µg Arm

EXPERIMENTAL

Participants receive 180 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.

Biological: AV-1980R 180 µg

Placebo Arm

PLACEBO COMPARATOR

Participants receive placebo injections (10 mM phosphate buffer with the adjuvant, no antigen) at Weeks 0, 4, 12, and 36.

Other: Placebo

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 20 µg Arm

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 60 µg Arm

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.

AV-1980R 180 µg Arm

Placebo OTHER

10 mM phosphate buffer formulated with the adjuvant; intramuscular injections at Weeks 0, 4, 12, and 36; no active antigen.

Placebo Arm

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for Molecular Medicine: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Comprehensive Center for Brain Health

Boca Raton, Florida, 33433, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Frontotemporal Dementia; Nerve Degeneration

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Agadjanyan, PhD

  Institute MM

  PRINCIPAL INVESTIGATOR

• Roman Kniazev

  Institute MM

  STUDY DIRECTOR

Central Study Contacts

Roman Kniazev

CONTACT

7145963981; rkniazev@immed.org

Anahit Ghochikyan

CONTACT

7145963981; aghochikyan@immed.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are randomized 3:1 within each cohort to AV-1980R or placebo. Arms reflect three dose levels (20, 60, 180 µg) and a pooled placebo; dosing at Weeks 0, 4, 12, and 36 with follow-up to Week 56.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 3:1 ratio to receive AV-1980R or placebo across three ascending dose cohorts. Each participant gets one assigned intervention in parallel with others.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 8, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): October 15, 2029
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)