NCT01117818

Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease

A Randomized, Controlled, Parallel Group, Double-blind, Multi-center, Phase II Study to Assess the Clinical- and Immunological Activity,as Well as the Safety and Tolerability of Different Doses/Formulations of AFFITOPE AD02 Administered Repeatedly to Patients With Early Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: Affiris AG · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.

Detailed description

AFFITOPE AD02 is a second generation AD immunotherapeutics targeting Aβ. Its active component is a synthetic peptide functionally mimicking the unmodified N-terminus of Aβ.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
BIOLOGICAL	active: AFFITOPE AD02	vaccination
BIOLOGICAL	control: Placebo	vaccination

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-05-06
• Last updated: 2013-12-11

Locations

31 sites across 6 countries: Austria, Croatia, Czechia, France, Germany, Slovakia