Phase 2Not yet recruitingAge-related condition
AV-1959R Vaccine in Individuals With Preclinical Alzheimer's Disease (SAGITTARIUS)
A Phase II, Randomized, Double-Blind Study to Evaluate Safety, Tolerability, Immunogenicity, and Amyloid-Lowering Effect of Amyloid-β Vaccine, AV-1959R, in Individuals With Preclinical Alzheimer's Disease.
- Sponsor
- Institute for Molecular Medicine (Academic or other)
- Enrolment
- 160 planned
- Conditions
- Preclinical Alzheimer's Disease; Alzheimer Disease
- Interventions
- AV-1959R; Placebo
- Ages
- adults, older adults
- Registry
- NCT07827768
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Incidence of Treatment-Emergent Adverse Events (TEAEs)
- Incidence of ARIA-E and ARIA-H
- Clinically Significant Changes in Safety Assessments
- Change From Baseline in Columbia-Suicide Severity Rating Scale Suicidal Ideation Severity Score
History
Primary completion expected
Expected to start
Last registry update
Registered
In the news
TrialsPR Newswire (opens PR Newswire in a new tab)
Nuravax reports AV-1959R amyloid-beta vaccine induced anti-Aβ antibodies in all 12 phase 1 recipients
The randomized, placebo-controlled trial enrolled 16 cognitively unimpaired participants, used two doses one month apart and was not powered for clinical efficacy; phase 2 is planned.
