NCT07107074

Effects of a Widely Used Vaccine Adjuvant in Subjects With Early Alzheimer's Disease Double-blind Study to Assess the Safety and Efficacy of AD04 in Patients With Early Alzheimer's Disease - ADVANCE

A Phase 2b, Multicenter, Randomized, Placebocontrolled, Double-blind Study to Assess the Safety and Efficacy of AD04 in Patients With Early Alzheimer's Disease - ADVANCE

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: ADvantage Therapeutics · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized, placebo-controlled phase 2b study is to prospectively evaluate AD04's potential as a disease-modifying drug in AD. By evaluating the safety, pharmacodynamics, and efficacy of AD04 in early AD patients, we aim to deliver a comprehensive and robust data set that furthers our understanding of the effects of AD04 in AD pathology.

Conditions

• Alzheimer Disease, Early Onset

Interventions

Type	Name	Description
DRUG	AD04	Each patient will receive 6 single s.c. injections of IMP at monthly intervals over a 5-month treatment period.
DRUG	Placebo	Each patient will receive 6 single s.c. injections of Placebo at monthly intervals over a 5-month treatment period.

Timeline

• Start date: 2023-11-08
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2025-08-06
• Last updated: 2025-08-06

Locations

3 sites across 2 countries: Austria, Poland