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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2029-10-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Alzheimer Disease Preclinical Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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AV-1980R 20 µg Arm

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

Group Type EXPERIMENTAL

AV-1980R 20 µg

Intervention Type 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 Arm

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

Group Type EXPERIMENTAL

AV-1980R 60 µg

Intervention Type 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 Arm

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

Group Type EXPERIMENTAL

AV-1980R 180 µg

Intervention Type 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 Arm

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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AV-1980R 20 µg

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.

Intervention Type BIOLOGICAL

AV-1980R 60 µg

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.

Intervention Type BIOLOGICAL

AV-1980R 180 µg

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.

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No