A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple-dose-escalation study evaluating the safety, tolerability, and immunogenicity of AV-1980R, an investigational vaccine targeting pathological tau, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65 to 80 years with biomarker evidence of preclinical Alzheimer's disease will be enrolled into three ascending-dose cohorts.
• Male or postmenopausal or surgically sterile female, 65 to 80 years of age, inclusive.
• Cognitively unimpaired participant with preclinical Alzheimer's disease who meets all of the following:
• Clinical Dementia Rating global score of 0 at Screening. Mini-Mental State Examination score ≥26, with education adjustment at Screening.
• Plasma p-tau217/Aβ42 ratio ≥0.00738 measured using Lumipulse (Fujirebio). A prior positive result obtained within 12 months before Screening may be accepted but must be confirmed by the central laboratory.
• Sight and hearing, including use of a hearing aid, sufficient to comply with study procedures.
• Stable concomitant medications. Participants receiving fluctuating medication or treatment may be considered if the underlying condition is controlled.
• Signed informed consent before any study-related procedure. Ability, in the Investigator's opinion, to understand the study and comply with protocol requirements.