Clinical trial NCT02008513: Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006
Official title: A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer´s Disease
Keywords: AFFITOPE® AD02
Alzheimer Disease
Dementia
Brain Disease
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Lead sponsor: Affiris AG
Sponsor class: INDUSTRY
First posted: 2013-12-11
Enrollment: 194
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.


Eligibility criteria: Inclusion Criteria:

* patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits
* 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:

* Pregnant women.
* 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.

Primary outcomes:
measure: Composite Measures of Primary Safety and Tolerability Endpoints
timeFrame: 19 months
Secondary outcomes:
measure: Composite Measures of Secondary Efficacy Endpoints
timeFrame: 19 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: 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: Psihijatrijska Bolnica Vrapče
city: Praha
country: Czech Republic
facility: University Thomayer Hospital
city: Praha
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
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: Ulm/Donau
country: Germany
facility: NeuroPoint GmbH
city: Kosice
country: Slovakia
facility: EPAMED, s.r.o.
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: