A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease
Institute for Molecular Medicine
Summary
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.
Description
This study will evaluate AV-1980R, a MultiTEP-based active immunotherapy formulated with Advax-CpG55.2 adjuvant, in participants with preclinical Alzheimer's disease. Up to 48 participants aged 65 to 80 years will be randomized in a 3:1 ratio to receive AV-1980R or placebo in three ascending-dose cohorts of 20 µg, 60 µg, and 180 µg. Participants will receive three intramuscular injections at Weeks 0, 4, and 38, with follow-up visits through Week 58. The primary objective is to evaluate safety and tolerability. Secondary objectives include evaluation of anti-tau antibody responses and T-cell r…
Eligibility
- Age range
- 65–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 he…