Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 335
- 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
- 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)
Opća bolnica Varaždin, Klinika za Neurologiju
🇭🇷Varaždin, Croatia
LNK Wagner-Jauregg, Dept. of geriatrics
🇦🇹Linz, Austria
MUW, Klin.Abt.f. Biolog. Psychiatrie
🇦🇹Vienna, Austria
Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt
🇦🇹Vienna, Austria
Centre Hospitalier Universitaire (CHU) de Dijon
🇫🇷Dijon, France
Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju
🇭🇷Rijeka, Croatia
"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju
🇭🇷Zagreb, Croatia
University Thomayer Hospital
🇨🇿Praha 4, Czech Republic
Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju
🇭🇷Zagreb, Croatia
Psihijatrijska Bolnica Vrapče
🇭🇷Zagreb, Croatia
University Hospital Motol, Clinic of Neurology
🇨🇿Praha 5, Czech Republic
CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard
🇫🇷Bordeaux Cedex, France
Hôpital Neurologique Pierre Wertheimer
🇫🇷Bron, France
Hôpital de la Pitié-Salpêtrière
🇫🇷Paris, France
CHU de rennes Site Hôtel Dieu
🇫🇷RENNES Cedex, France
Centre Mémoire de Ressources et de Recherche, Service de Neurologie
🇫🇷Montpellier Cedex 05, France
Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie
🇩🇪Mannheim, Germany
Hopital La Grave
🇫🇷Toulouse, France
Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie
🇩🇪Berlin, Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie
🇩🇪Hamburg, Germany
Studienzentrum PD Dr. Steinwachs
🇩🇪Nürnberg, Germany
NeuroPoint GmbH
🇩🇪Ulm/Donau, Germany
Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München
🇩🇪Munich, Germany
Arzneimittelforschung Leipzig GmbH, Studienzentrum
🇩🇪Leipzig, Germany
Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie
🇩🇪Nürnberg, Germany
Psychiatric Hospital Michalovce
🇸🇰Michalovce, Slovakia
Landeskrankenhaus Hall Gedächtnisambulanz
🇦🇹Hall in Tirol, Austria
SMZ-Ost, Psychiatric Dep.
🇦🇹Vienna, Austria
MUW Klin. Pharmakologie und Klinik für Neurologie
🇦🇹Vienna, Austria
EPAMED, s.r.o.
🇸🇰Kosice, Slovakia
Christian Doppler Klinik, Univ. Klinik f. Neurologie
🇦🇹Salzburg, Austria