AzTrials
AzTrials

Alzheimer DiseasePhase 1TAURUS-1980NCT07158905

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

A Phase 1 study testing AV-1980R 20 µg, AV-1980R 60 µg and AV-1980R 180 µg in people with Alzheimer Disease and Preclinical Alzheimer's Disease, run by Institute for Molecular Medicine at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 years
What is being tested?
AV-1980R 20 µg, AV-1980R 60 µg and AV-1980R 180 µg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
6 sitesUnited States
Study dates
23 Jun 2026to 15 Oct 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Roman Kniazev contact

7145963981

rkniazev@immed.org

Anahit Ghochikyan contact

7145963981

aghochikyan@immed.org

6 sites in 1 country

United States6 sites, 6 recruiting
  • Comprehensive Center for Brain Health

    Boca Raton, Florida, 33433

    Shanell Disla, 561-869-6825, sxd1210@med.miami.edu

    Alyssa Gosling, 561-869-6820, aeg364@med.miami.edu

    Recruiting
  • Alzheimer's Research and Treatment Center (Columbus)

    Columbus, Georgia, 31904

    Dawn Pitman, 776-653-8455, dpitman@researchalz.com

    Kylie Gilbert, 706-653-8455, kgilbert@researchalz.com

    Recruiting
  • Palm Springs Community Health Center

    Miami Lakes, Florida, 33014

    Mailin Perez, 305-431-7493, mperez@palmspringschc.com

    Vivianne Gonzalez, 786-334-6675, vgonzalez@palmspringschc.com

    Recruiting
  • Alzheimer's Research and Treatment Center (Stuart)

    Stuart, Florida, 34996

    Cristina Healy, 772-675-0000, cchirino@researchalz.com

    Emma LaVopa, 772-675-0000, elavopa@researchalz.com

    Recruiting
  • University of South Florida

    Tampa, Florida, 33613

    Randa Abdulkarim, 656-244-6936, randaa@usf.edu

    Genesis Estremera, 813-440-9452, gestremera@usf.edu

    Recruiting
  • Alzheimer's Research and Treatment Center (Wellington)

    Wellington, Florida, 33414

    Megan Moran, 561-209-2400, mmoran@researchalz.com

    Jasmine Flores, 561-209-2400, jflores@researchalz.com

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

This study will evaluate AV-1980R, a MultiTEP-based active immunotherapy formulated with Advax-CpG55.2 adjuvant, in participants with preclinical Alzheimer's disease. Up to 48 participants aged 65 to 80 years will be randomized in a 3:1 ratio to receive AV-1980R or placebo in three ascending-dose cohorts of 20 µg, 60 µg, and 180 µg.

Participants will receive three intramuscular injections at Weeks 0, 4, and 38, with follow-up visits through Week 58. The primary objective is to evaluate safety and tolerability. Secondary objectives include evaluation of anti-tau antibody responses and T-cell responses. Exploratory assessments include plasma Alzheimer's disease biomarkers, tau PET imaging, immune-response characteristics, and cognitive measures.

Being tested
AV-1980R 20 µg, AV-1980R 60 µg, AV-1980R 180 µg, Placebo
Keywords
Tau protein, Immunotherapy, Vaccine, Preclinical Alzheimer's Disease, Alzheimer's Disease, secondary prevention, Neurodegeneration, Preventive Alzheimer's
Medical subject headings
Alzheimer Disease, Frontotemporal Dementia, Nerve Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AV-1980R 20 µgBiological

    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 60 µgBiological

    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 180 µgBiological

    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.

  • PlaceboOther

    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.

Study groups in NCT07158905
Study groupRoleWhat they receive
AV-1980R 20 µg ArmExperimentalParticipants receive 20 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.
Receives: Biological: AV-1980R 20 µg
AV-1980R 60 µg ArmExperimentalParticipants receive 60 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.
Receives: Biological: AV-1980R 60 µg
AV-1980R 180 µg ArmExperimentalParticipants receive 180 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.
Receives: Biological: AV-1980R 180 µg
Placebo ArmPlacebo comparatorParticipants receive 10 mM phosphate buffer without active AV-1980R, formulated with Advax-CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline through Week 58

Secondary outcomes (10)
  1. Number of Participants with Clinically Significant Changes in Vital Signs

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

    Measured: Baseline through Week 58

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

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

    Measured: Baseline through Week 58

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

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

    Measured: Baseline through Week 58

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

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

    Measured: Screening through Week 58

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

    Number of participants with new or worsening abnormal neurological findings.

    Measured: Screening through Week 58

  6. Number of Participants with New MRI Abnormalities, Including ARIA-E and ARIA-H

    Number of participants with new MRI findings of vasogenic edema or sulcal effusion (ARIA-E), cerebral microhemorrhage, macrohemorrhage, or superficial siderosis (ARIA-H), or new ischemic findings.

    Measured: Screening and Weeks 6, 40, and 58

  7. Change from Baseline in Columbia-Suicide Severity Rating Scale Assessment

    Change from baseline in suicidal ideation and behavior assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS).

    Measured: Baseline and Weeks 38, 40, 50, and 58

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

    Serum anti-tau antibody titers measured using a validated enzyme-linked immunosorbent assay.

    Measured: Baseline through Week 58

  9. Change from Baseline in MultiTEP-Specific T-Helper Cell Responses

    MultiTEP-specific interferon-gamma-producing T-helper cells detected in peripheral blood mononuclear cells using an ELISPOT assay after stimulation with MultiTEP T-helper peptides.

    Measured: Baseline through Week 58

  10. Change from Baseline in Tau-Specific Autoreactive T-Helper Cell Responses

    Tau-specific interferon-gamma-producing T-helper cells detected in peripheral blood mononuclear cells using an ELISPOT assay after stimulation with the Tau2-18 peptide.

    Measured: Baseline through Week 58

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start23 Jun 2026
  3. Primary completion15 Jun 2029 (estimated)
  4. Study completion15 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07158905
Sponsor's protocol ID
IMM-AV1980R-102
Other IDs
1R01AG092949-01
Acronym
TAURUS-1980
Status last verified
Jul 2026
First submitted
27 Aug 2025
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AV-1980R 20 µg, AV-1980R 60 µg and AV-1980R 180 µg in people with Alzheimer Disease and Preclinical Alzheimer's Disease, run by Institute for Molecular Medicine at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roman Kniazev (7145963981, rkniazev@immed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events (time frame: Baseline through Week 58). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in