Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006
NCT ID: NCT02008513
Last Updated: 2015-06-24
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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TERMINATED
PHASE2
194 participants
INTERVENTIONAL
2013-06-30
2014-09-30
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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Group 1
AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations
AFFITOPE® AD02
Group 2
AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations
AFFITOPE® AD02
Placebo
Interventions
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AFFITOPE® AD02
Placebo
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Availability of a partner/caregiver
* Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
* Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.
Exclusion Criteria
* Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
* Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.
* History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
* Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
* Contraindication for MRI imaging
* Presence and/or history of immunodeficiency (e.g., HIV infection).
* Prior and/or current treatment with experimental immunotherapeutics including Intravenous immunoglobulin (IVIG), AD antibody therapy and/or vaccines for AD except AD02.
* Prior and/or current treatment with immunosuppressive drugs.
* Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment.
* Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.
50 Years
85 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
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
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
NeuroPoint GmbH
Ulm/Donau, , Germany
EPAMED, s.r.o.
Košice, , Slovakia
Countries
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Other Identifiers
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2012-005280-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AFF006A
Identifier Type: -
Identifier Source: org_study_id
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