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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016504-22 | EudraCT Number |
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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.
AFFITOPE AD02 is a second generation AD immunotherapeutics targeting Aβ. Its active component is a synthetic peptide functionally mimicking the unmodified N-terminus of Aβ.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: AFFITOPE AD02 | Active Comparator |
| |
| B: AFFITOPE AD02 | Active Comparator |
| |
| C: AFFITOPE AD02 | Active Comparator |
| |
| D: Placebo control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active: AFFITOPE AD02 | Biological | vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| cognitive(ADAS-cog modified) and functional(ADCS-ADL modified) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI) | 18 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40953123 | Derived | Haaland B, Dickson SP, Santana AF, Tanzi RE, Dubois B, Peters O, Grimmer T, Christensen J, Mallinckrodt C, Schneeberger A, Hendrix SB. Efficacy of AD04, an aluminum-based vaccine adjuvant, in patients with early Alzheimer's disease: Post hoc analysis of AFF006 (NCT01117818), a proof-of-concept, phase 2 randomized controlled trial. J Alzheimers Dis. 2025 Nov;108(1):234-242. doi: 10.1177/13872877251375985. Epub 2025 Sep 15. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 19, 2017 | |
| Reset | Jul 26, 2018 |
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| control: Placebo | Biological | vaccination |
|
|
| 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 19, 2017 | Jul 26, 2018 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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