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

NCT07158905 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IMM-AV1980R-1021R01AG092949-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

Brief Summary

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple-dose-escalation study evaluating the safety, tolerability, and immunogenicity of AV-1980R, an investigational vaccine targeting pathological tau, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65 to 80 years with biomarker evidence of preclinical Alzheimer's disease will be enrolled into three ascending-dose cohorts.

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)

• Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events

  Number of participants who experience one or more treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs), summarized by severity and relationship to study intervention.

  Baseline through Week 58

Secondary Outcomes (10)

• Number of Participants with Clinically Significant Changes in Vital Signs

  Baseline through Week 58

• Number of Participants with Clinically Significant Changes in ECG Results

  Baseline through Week 58

• Number of Participants with Clinically Significant Changes in Laboratory Tests

  Baseline through Week 58

• Number of Participants with Clinically Significant Changes in Physical Examinations

  Screening through Week 58

• Number of Participants with Clinically Significant Changes in Neurological Examinations

  Screening through Week 58

Other Outcomes (9)

• Change from Baseline in Plasma Alzheimer's Disease Biomarker Concentrations

  Baseline through Week 58

• Change from Baseline in Serum Immunoglobulin Isotypes and IgG Subclasses

  Baseline through Week 58

• Change from Baseline in Activated T-Cell Subsets

  Baseline through Week 58

Study Arms (4)

AV-1980R 20 µg Arm

EXPERIMENTAL

Participants receive 20 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.

Biological: AV-1980R 20 µg

AV-1980R 60 µg Arm

EXPERIMENTAL

Participants receive 60 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.

Biological: AV-1980R 60 µg

AV-1980R 180 µg Arm

EXPERIMENTAL

Participants receive 180 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.

Biological: AV-1980R 180 µg

Placebo Arm

PLACEBO COMPARATOR

Participants receive 10 mM phosphate buffer without active AV-1980R, formulated with Advax-CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.

Other: Placebo

Interventions

AV-1980R 180 µg BIOLOGICAL

AV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 180 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.

AV-1980R 180 µg Arm

Placebo OTHER

The placebo consists of 10 mM phosphate buffer without active AV-1980R, formulated with Advax-CpG55.2, consisting of Advax and CpG55.2. It is administered by intramuscular injection at Weeks 0, 4, and 38.

Placebo Arm

AV-1980R 20 µg BIOLOGICAL

AV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 20 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.

AV-1980R 20 µg Arm

AV-1980R 60 µg BIOLOGICAL

AV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 60 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.

AV-1980R 60 µg Arm

Eligibility Criteria

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

You may qualify if:

• Male or postmenopausal or surgically sterile female, 65 to 80 years of age, inclusive.
• Cognitively unimpaired participant with preclinical Alzheimer's disease who meets all of the following:
• Clinical Dementia Rating global score of 0 at Screening. Mini-Mental State Examination score ≥26, with education adjustment at Screening.
• Plasma p-tau217/Aβ42 ratio ≥0.00738 measured using Lumipulse (Fujirebio). A prior positive result obtained within 12 months before Screening may be accepted but must be confirmed by the central laboratory.
• Sight and hearing, including use of a hearing aid, sufficient to comply with study procedures.
• Stable concomitant medications. Participants receiving fluctuating medication or treatment may be considered if the underlying condition is controlled.
• Signed informed consent before any study-related procedure. Ability, in the Investigator's opinion, to understand the study and comply with protocol requirements.

You may not qualify if:

• Screening MRI showing any of the following:
• More than one noncortical lacunar infarct greater than 1.5 cm. Any territorial infarct greater than 1.5 cm. Combined microbleeds and areas of leptomeningeal hemosiderosis greater than 5, or disseminated leptomeningeal hemosiderosis.
• Any other significant cerebral abnormality, including ARIA-E. Contraindication to MRI, including non-MRI-safe implanted metallic devices or clinically significant claustrophobia.
• Serious illness requiring systemic treatment or hospitalization within 4 weeks before study entry.
• Clinically relevant cardiovascular, respiratory, gastrointestinal, endocrine, immunologic, hematologic, systemic disease, or major surgery that could interfere with participation or follow-up.
• Insulin-dependent diabetes. Clinically relevant cardiac arrhythmia, palpitation, conduction abnormality, prolonged QT interval, or bundle branch block.
• Pre-existing autoimmune disease. C-SSRS score of 3 or higher. History of seizure disorder, except permitted stable use of certain antiepileptic medications for chronic pain.
• Any medical, psychological, or social condition that could interfere with participation, compliance, or participant safety.
• Participation in another investigational drug study or use of an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing.
• Prior tau or amyloid-beta immunotherapy within 1 year before Screening. Use of specified immunomodulatory or growth-stimulating treatments within 30 days before study entry.
• Chronic use for more than 3 months of warfarin, other coumarin derivatives, anticoagulants, or an antiplatelet agent such as clopidogrel.
• Parenteral immunoglobulin preparations, blood products, or plasma derivatives. History of severe local or systemic vaccination reactions or significant allergic reactions.
• Clinically significant laboratory abnormalities at Screening, including ALT or AST greater than 1.5 times the upper limit of normal.
• Positive testing for HIV-1 or HIV-2, hepatitis B surface antigen, or hepatitis C.

Sponsors & Collaborators

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

Study Sites (6)

Comprehensive Center for Brain Health

Boca Raton, Florida, 33433, United States

RECRUITING

Palm Springs Community Health Center

Miami Lakes, Florida, 33014, United States

RECRUITING

Alzheimer's Research and Treatment Center (Stuart)

Stuart, Florida, 34996, United States

RECRUITING

University of South Florida

Tampa, Florida, 33613, United States

RECRUITING

Alzheimer's Research and Treatment Center (Wellington)

Wellington, Florida, 33414, United States

RECRUITING

Alzheimer's Research and Treatment Center (Columbus)

Columbus, Georgia, 31904, United States

RECRUITING

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: The study is double-blind. Participants and clinical staff administering the investigational product will not know whether AV-1980R or placebo was assigned. The randomization schedule will be maintained in the interactive response technology system, and the AV-1980R and placebo vials will be masked to maintain the blind. Emergency unblinding is permitted only when treatment assignment is necessary for the participant's medical care.
• 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: June 23, 2026
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): October 15, 2029
• Last Updated: August 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)