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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

NCT07107074 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-08-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • ADvantage Therapeutics

    lead OTHER

Principal Investigators

  • Achim Schneeberger, MD · ADvantage Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Austria
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07107074 on ClinicalTrials.gov