Status:
NOT_YET_RECRUITING
AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)
Lead Sponsor:
Institute for Molecular Medicine
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Preclinical Alzheimer's Disease
Eligibility:
All Genders
65-80 years
Phase:
PHASE1
Brief Summary
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 v...
Detailed Description
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 randomiz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2029
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07158905
Start Date
December 15 2025
End Date
October 15 2029
Last Update
September 8 2025
Active Locations (1)
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1
Comprehensive Center for Brain Health
Boca Raton, Florida, United States, 33433