Clinical trial NCT01117818: Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Affiris AG
Sponsor class: INDUSTRY
First posted: 2010-05-06
Enrollment: 335
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)
timeFrame: 18 months
Secondary outcomes:
measure: cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)
timeFrame: 18 months
Other outcomes:
Locations:
city: Hall in Tirol
country: Austria
facility: Landeskrankenhaus Hall Gedächtnisambulanz
city: Linz
country: Austria
facility: LNK Wagner-Jauregg, Dept. of geriatrics
city: Salzburg
country: Austria
facility: Christian Doppler Klinik, Univ. Klinik f. Neurologie
city: Vienna
country: Austria
facility: Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt
city: Vienna
country: Austria
facility: MUW Klin. Pharmakologie und Klinik für Neurologie
city: Vienna
country: Austria
facility: MUW, Klin.Abt.f. Biolog. Psychiatrie
city: Vienna
country: Austria
facility: SMZ-Ost, Psychiatric Dep.
city: Rijeka
country: Croatia
facility: Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju
city: Varaždin
country: Croatia
facility: Opća bolnica Varaždin, Klinika za Neurologiju
city: Zagreb
country: Croatia
facility: "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju
city: Zagreb
country: Croatia
facility: Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju
city: Zagreb
country: Croatia
facility: Psihijatrijska Bolnica Vrapče
city: Praha 4
country: Czech Republic
facility: University Thomayer Hospital
city: Praha 5
country: Czech Republic
facility: University Hospital Motol, Clinic of Neurology
city: Bordeaux Cedex
country: France
facility: CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard
city: Bron
country: France
facility: Hôpital Neurologique Pierre Wertheimer
city: Dijon
country: France
facility: Centre Hospitalier Universitaire (CHU) de Dijon
city: Montpellier Cedex 05
country: France
facility: Centre Mémoire de Ressources et de Recherche, Service de Neurologie
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière
city: RENNES Cedex
country: France
facility: CHU de rennes Site Hôtel Dieu
city: Toulouse
country: France
facility: Hopital La Grave
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie
city: Leipzig
country: Germany
facility: Arzneimittelforschung Leipzig GmbH, Studienzentrum
city: Mannheim
country: Germany
facility: Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie
city: Munich
country: Germany
facility: Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München
city: Nürnberg
country: Germany
facility: Studienzentrum PD Dr. Steinwachs
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie
city: Ulm/Donau
country: Germany
facility: NeuroPoint GmbH
city: Kosice
country: Slovakia
facility: EPAMED, s.r.o.
city: Michalovce
country: Slovakia
facility: Psychiatric Hospital Michalovce
Study officials:
affiliation: Centre des Maladies Cognitives et Comportementales, Federation des maladies du systeme nerveux, Hoptial de la Salpetriere, Pavillon Paul Castaignes (Sous-sol), 47-83 Bd de l'Hopital, 75651 Paris Cedex 13
name: Bruno Dubois, Prof
role: PRINCIPAL_INVESTIGATOR
References: