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

Phase 2

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT01117818
• Lead Sponsor: Affiris AG

Brief 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.

Study Timeline

• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-06
• Study Start: 2010-09
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• Informed consent capability
• Early AD, based on episodic memory deficit and hippocampal atrophy
• Age from 50 to 80, inclusive
• MMSE of 20+
• Brain magnetic resonance imaging scan consistent with the diagnosis of AD
• Stable doses of medications (cholinesterase inhibitors and memantine allowed)
• Caregiver able to attend all visits with patient

Exclusion Criteria

• Significant neurological disease other than AD
• Major psychiatric illness
• Significant systemic illness
• Autoimmune disease
• Prior treatment with experimental immunotherapeutics for AD including IVIG
• Women of childbearing potential without birth control
• Contraindication for MRI scan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)	18 months

Secondary Outcome Measures

Name	Time	Method
cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)	18 months

Trial Locations

Locations (31)

Landeskrankenhaus Hall Gedächtnisambulanz; 🇦🇹 Hall in Tirol, Austria

LNK Wagner-Jauregg, Dept. of geriatrics; 🇦🇹 Linz, Austria

Christian Doppler Klinik, Univ. Klinik f. Neurologie; 🇦🇹 Salzburg, Austria

Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt; 🇦🇹 Vienna, Austria

MUW Klin. Pharmakologie und Klinik für Neurologie; 🇦🇹 Vienna, Austria

MUW, Klin.Abt.f. Biolog. Psychiatrie; 🇦🇹 Vienna, Austria

SMZ-Ost, Psychiatric Dep.; 🇦🇹 Vienna, Austria

Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju; 🇭🇷 Rijeka, Croatia

Opća bolnica Varaždin, Klinika za Neurologiju; 🇭🇷 Varaždin, Croatia

"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju; 🇭🇷 Zagreb, Croatia

Scroll for more (21 remaining)