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
2 other identifiers
interventional
335
6 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2010
Typical duration for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 6, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 11, 2013
December 1, 2013
3.3 years
April 19, 2010
December 10, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)
18 months
Secondary Outcomes (1)
cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)
18 months
Study Arms (4)
A: AFFITOPE AD02
ACTIVE COMPARATORB: AFFITOPE AD02
ACTIVE COMPARATORC: AFFITOPE AD02
ACTIVE COMPARATORD: Placebo control
ACTIVE COMPARATORInterventions
vaccination
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Affiris AGlead
Study Sites (31)
Landeskrankenhaus Hall Gedächtnisambulanz
Hall in Tirol, 6060, Austria
LNK Wagner-Jauregg, Dept. of geriatrics
Linz, 4020, Austria
Christian Doppler Klinik, Univ. Klinik f. Neurologie
Salzburg, 5020, Austria
Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt
Vienna, 1080, Austria
MUW Klin. Pharmakologie und Klinik für Neurologie
Vienna, 1090, Austria
MUW, Klin.Abt.f. Biolog. Psychiatrie
Vienna, 1090, Austria
SMZ-Ost, Psychiatric Dep.
Vienna, 1220, Austria
Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju
Rijeka, 51000, Croatia
Opća bolnica Varaždin, Klinika za Neurologiju
Varaždin, 42000, Croatia
"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju
Zagreb, 10000, Croatia
Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju
Zagreb, 10000, Croatia
Psihijatrijska Bolnica Vrapče
Zagreb, 10090, Croatia
University Thomayer Hospital
Prague, 149 50, Czechia
University Hospital Motol, Clinic of Neurology
Prague, 150 06, Czechia
CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard
Bordeaux, 33076, France
Hôpital Neurologique Pierre Wertheimer
Bron, 69500, France
Centre Hospitalier Universitaire (CHU) de Dijon
Dijon, 21033, France
Centre Mémoire de Ressources et de Recherche, Service de Neurologie
Montpellier, 34295, France
Hôpital de la Pitié-Salpêtrière
Paris, 75651, France
CHU de rennes Site Hôtel Dieu
Rennes, 35064, France
Hopital La Grave
Toulouse, 31059, France
Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie
Berlin, 14050, Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie
Hamburg, 20251, Germany
Arzneimittelforschung Leipzig GmbH, Studienzentrum
Leipzig, 04107, Germany
Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie
Mannheim, 68159, Germany
Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München
Munich, 81675, Germany
Studienzentrum PD Dr. Steinwachs
Nuremberg, 90402, Germany
Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie
Nuremberg, 90419, Germany
NeuroPoint GmbH
Ulm/Donau, 89073, Germany
EPAMED, s.r.o.
Košice, 040 17, Slovakia
Psychiatric Hospital Michalovce
Michalovce, 071 01, Slovakia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno Dubois, Prof
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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2010
First Posted
May 6, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 11, 2013
Record last verified: 2013-12