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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005280-27 | EudraCT Number |
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Study AFF006A was early terminated by the sponsor based on the results of study AFF006.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations |
|
| Group 2 | Active Comparator | AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFFITOPE® AD02 | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Measures of Primary Safety and Tolerability Endpoints |
| 19 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Measures of Secondary Efficacy Endpoints |
| 19 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Hall Gedächtnisambulanz | Hall in Tirol | 6060 | Austria | |||
| LNK Wagner-Jauregg, Dept. of geriatrics |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 19, 2017 | |
| Reset | Jul 27, 2018 |
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|
| Linz |
| 4020 |
| Austria |
| Christian Doppler Klinik, Univ. Klinik f. Neurologie | Salzburg | 5020 | 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 |
| Psihijatrijska Bolnica Vrapče | Zagreb | 10090 | Croatia |
| University Thomayer Hospital | Prague | 14950 | Czechia |
| University Hospital Motol, Clinic of Neurology | Prague | 15006 | 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 |
| NeuroPoint GmbH | Ulm/Donau | 89073 | Germany |
| EPAMED, s.r.o. | Košice | 04017 | Slovakia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 19, 2017 | Jul 27, 2018 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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