AV-1959R Vaccine in Individuals With Preclinical Alzheimer's Disease

Study acronym: SAGITTARIUS
StatusNot Yet Recruiting
PhasePhase 2
Started

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Primary endpoint reworded 1 of 5 changed
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Record History

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  1. Eligibility criteria expanded, about 10 words
  2. Primary endpoint(s) modified
    • Study title shortened, about 3 words
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This Phase 2 study will evaluate the safety, tolerability, immunogenicity, and amyloid-lowering effect of AV-1959R in cognitively unimpaired adults with preclinical Alzheimer's disease. Approximately 160 participants will be randomized to receive AV-1959R or placebo and will be followed for 78 weeks. The study will assess safety, immune responses, brain amyloid, and Alzheimer's disease-related biomarkers.
Trial Details
NCT Number NCT07827768
Lead Sponsor Institute for Molecular Medicine
Collaborators: Nuravax, Inc.
Conditions
(from sponsor)		 Preclinical Alzheimer's Disease, Alzheimer Disease
Related terms Alzheimer Disease, Plaque, Amyloid
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov