Skip to main content
Delfa

← Trials/Trial dossier/NCT07158905

TAURUS-1980

RecruitingPhase 1

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

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

Asset

AV-1980R

Listed sites

3

Recruiting sites

2

Enrollment

48

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Preclinical/asymptomatic AD•CDR global 0•MMSE ≥26•MRI contraindications excluded

Primary endpoint

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

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1R01AG092949-01
Org study IDIMM-AV1980R-102
NCT IDNCT07158905

Timeline

Milestones

Study first posted2025-09-08actual
Study start2026-06-23actual
Last update posted2026-06-26actual
Primary completion2029-06-15estimated
Study completion2029-10-15estimated

Assets

Drug assets

AV-1980R

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
11
Amyloid biomarkers
3
Behavior / neuropsychiatric
1
Neuroimaging
1
Safety / tolerability / PK
1

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

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

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

change from baseline, improvement

Amyloid biomarkers

3 endpoints
Secondary/protocol endpoint

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

Time frame:Baseline through Week 56

event count, event

Other/protocol endpoint

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

Time frame:Baseline through Week 56

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Other/protocol endpoint

Change from Baseline in Plasma Biomarker Ratios

Time frame:Time Frame: Baseline through Week 56

change from baseline, improvement

Neuroimaging

1 endpoint
Primary/protocol endpoint

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

Time frame:Baseline through Week 56

event count, event

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of Participants with Clinically Significant Changes in Vital Signs

Time frame:Baseline through Week 56

event count, event

Other (unclassified)

11 endpoints
Secondary/protocol endpoint/low confidence

Number of Participants with Clinically Significant Changes in ECG Results

Time frame:Baseline through Week 56

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants with Clinically Significant Changes in Laboratory Tests

Time frame:Baseline through Week 56

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants with Clinically Significant Changes in Physical Examinations

Time frame:Baseline through Week 56

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants with Clinically Significant Changes in Neurological Examinations

Time frame:Baseline through Week 56

event count, event

Secondary/protocol endpoint/low confidence

Change from Baseline in Serum Anti-Tau Antibody Concentrations

Time frame:Baseline through Week 56

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline through Week 56

descriptive

Secondary/protocol endpoint/low confidence

Detection of Autoreactive Th-Cell Responses Specific to Tau

Time frame:Baseline through Week 56

descriptive

Other/protocol endpoint/low confidence

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

Time frame:Baseline through Week 56

change from baseline, improvement

Other/protocol endpoint/low confidence

Phenotyping of Activated T Cells

Time frame:Baseline through Week 56

descriptive

Other/protocol endpoint/low confidence

T Cell Proliferative Response

Time frame:Baseline through Week 56

descriptive

Other/protocol endpoint/low confidence

Polarization of Cellular Responses

Time frame:Baseline through Week 56

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.