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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117818
• Other study ID #: AFF006
• Secondary ID: 2009-016504-22
• Status: Completed
• Phase: Phase 2
• First received: April 19, 2010
• Last updated: December 10, 2013
• Start date: September 2010
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Affiris AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• active: AFFITOPE AD02
vaccination
• control: Placebo
vaccination

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Hall Gedächtnisambulanz	Hall in Tirol
Austria	LNK Wagner-Jauregg, Dept. of geriatrics	Linz
Austria	Christian Doppler Klinik, Univ. Klinik f. Neurologie	Salzburg
Austria	MUW Klin. Pharmakologie und Klinik für Neurologie	Vienna
Austria	MUW, Klin.Abt.f. Biolog. Psychiatrie	Vienna
Austria	SMZ-Ost, Psychiatric Dep.	Vienna
Austria	Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt	Vienna
Croatia	Klincki Bolnicki Centar Rijeka, Klinika za Psihijatriju	Rijeka
Croatia	Opca bolnica Varaždin, Klinika za Neurologiju	Varaždin
Croatia	"BONIFARM" Poliklinika za klinicku farmakologiju i toksikologiju	Zagreb
Croatia	Klincki Bolnicki Centar Zagreb (REBRO), Klinika za Neurologiju	Zagreb
Croatia	Psihijatrijska Bolnica Vrapce	Zagreb
Czech Republic	University Thomayer Hospital	Praha 4
Czech Republic	University Hospital Motol, Clinic of Neurology	Praha 5
France	CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard	Bordeaux Cedex
France	Hôpital Neurologique Pierre Wertheimer	Bron
France	Centre Hospitalier Universitaire (CHU) de Dijon	Dijon
France	Centre Mémoire de Ressources et de Recherche, Service de Neurologie	Montpellier Cedex 05
France	Hôpital de la Pitié-Salpêtrière	Paris
France	CHU de rennes Site Hôtel Dieu	RENNES Cedex
France	Hopital La Grave	Toulouse
Germany	Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie	Berlin
Germany	Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie	Hamburg
Germany	Arzneimittelforschung Leipzig GmbH, Studienzentrum	Leipzig
Germany	Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie	Mannheim
Germany	Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München	Munich
Germany	Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie	Nürnberg
Germany	Studienzentrum PD Dr. Steinwachs	Nürnberg
Germany	NeuroPoint GmbH	Ulm/Donau
Slovakia	EPAMED, s.r.o.	Kosice
Slovakia	Psychiatric Hospital Michalovce	Michalovce

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Countries where clinical trial is conducted

Austria,  Croatia,  Czech Republic,  France,  Germany,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)		18 months
Secondary	cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)		18 months