AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65-80
SponsorInstitute for Molecular Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
AV-1980R 20 µg
Biological/VaccineMultiTEP-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
Biological/VaccineMultiTEP-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
Biological/VaccineMultiTEP-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
Other intervention10 mM phosphate buffer formulated with the adjuvant; intramuscular injections at Weeks 0, 4, 12, and 36; no active antigen.
Treatment groups
48 Participants
are divided into 4 treatment groupsGroup A: AV-1980R 20 µg ArmExperimental treatment 1 intervention
Group B: AV-1980R 60 µg ArmExperimental treatment 1 intervention
Group C: AV-1980R 180 µg ArmExperimental treatment 1 intervention
Group D: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline through Week 56Secondary outcomes
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.
Time frame
Baseline through Week 562
Number of Participants with Clinically Significant Changes in ECG Results
Number of participants with new or worsening clinically significant ECG abnormalities.
Time frame
Baseline through Week 563
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.
Time frame
Baseline through Week 564
Number of Participants with Clinically Significant Changes in Physical Examinations
Number of participants with new or worsening abnormal findings on physical examination.
Time frame
Baseline through Week 56Other outcomes
1
Change from Baseline in Plasma Biomarker Concentrations (pg/mL)
Change in plasma concentrations of Aβ42, Aβ40, pTau217, pTau181, pTau231, total tau (t-tau), neurofilament light (NfL), and glial fibrillary acidic protein (GFAP), reported in pg/mL.
Time frame
Baseline through Week 562
Change from Baseline in Immunoglobulin Isotypes and Subclasses (mg/dL)
Change in serum concentrations of IgM, total IgG, and IgG subclasses (IgG1, IgG2, IgG3, IgG4), reported in mg/dL
Time frame
Baseline through Week 563
Phenotyping of Activated T Cells
Characterization of activated T cell subsets by flow cytometry.
Time frame
Baseline through Week 564
T Cell Proliferative Response
Assessment of proliferative capacity of T cells following antigen stimulation.
Time frame
Baseline through Week 56Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute for Molecular Medicine
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov