Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease
NCT ID: NCT01117818
Last Updated: 2013-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
335 participants
INTERVENTIONAL
2010-09-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A: AFFITOPE AD02
active: AFFITOPE AD02
vaccination
B: AFFITOPE AD02
active: AFFITOPE AD02
vaccination
C: AFFITOPE AD02
active: AFFITOPE AD02
vaccination
D: Placebo control
control: Placebo
vaccination
Interventions
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active: AFFITOPE AD02
vaccination
control: Placebo
vaccination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
No
Sponsors
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Affiris AG
INDUSTRY
Responsible Party
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Principal Investigators
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Bruno Dubois, Prof
Role: PRINCIPAL_INVESTIGATOR
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
Locations
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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
Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju
Zagreb, , Croatia
Psihijatrijska Bolnica Vrapče
Zagreb, , Croatia
University Thomayer Hospital
Prague, , Czechia
University Hospital Motol, Clinic of Neurology
Prague, , Czechia
CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard
Bordeaux, , 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, , France
Hôpital de la Pitié-Salpêtrière
Paris, , France
CHU de rennes Site Hôtel Dieu
Rennes, , France
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
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
Studienzentrum PD Dr. Steinwachs
Nuremberg, , Germany
Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie
Nuremberg, , Germany
NeuroPoint GmbH
Ulm/Donau, , Germany
EPAMED, s.r.o.
Košice, , Slovakia
Psychiatric Hospital Michalovce
Michalovce, , Slovakia
Countries
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Other Identifiers
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2009-016504-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AFF006
Identifier Type: -
Identifier Source: org_study_id