Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT01117818
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2010-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-07-26', 'releaseDate': '2017-10-19'}], 'estimatedResultsFirstSubmitDate': '2017-10-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 335}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2010-04-19', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent capability\n* Early AD, based on episodic memory deficit and hippocampal atrophy\n* Age from 50 to 80, inclusive\n* MMSE of 20+\n* Brain magnetic resonance imaging scan consistent with the diagnosis of AD\n* Stable doses of medications (cholinesterase inhibitors and memantine allowed)\n* Caregiver able to attend all visits with patient\n\nExclusion Criteria:\n\n* Significant neurological disease other than AD\n* Major psychiatric illness\n* Significant systemic illness\n* Autoimmune disease\n* Prior treatment with experimental immunotherapeutics for AD including IVIG\n* Women of childbearing potential without birth control\n* Contraindication for MRI scan'}, 'identificationModule': {'nctId': 'NCT01117818', 'briefTitle': "Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Affiris AG'}, 'officialTitle': "A Randomized, Controlled, Parallel Group, Double-blind, Multi-center, Phase II Study to Assess the Clinical- and Immunological Activity,as Well as the Safety and Tolerability of Different Doses/Formulations of AFFITOPE AD02 Administered Repeatedly to Patients With Early Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'AFF006'}, 'secondaryIdInfos': [{'id': '2009-016504-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A: AFFITOPE AD02', 'interventionNames': ['Biological: active: AFFITOPE AD02']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B: AFFITOPE AD02', 'interventionNames': ['Biological: active: AFFITOPE AD02']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C: AFFITOPE AD02', 'interventionNames': ['Biological: active: AFFITOPE AD02']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D: Placebo control', 'interventionNames': ['Biological: control: Placebo']}], 'interventions': [{'name': 'active: AFFITOPE AD02', 'type': 'BIOLOGICAL', 'otherNames': ['AFFITOPE AD02'], 'description': 'vaccination', 'armGroupLabels': ['A: AFFITOPE AD02', 'B: AFFITOPE AD02', 'C: AFFITOPE AD02']}, {'name': 'control: Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['placebo', 'control'], 'description': 'vaccination', 'armGroupLabels': ['D: Placebo control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6060', 'city': 'Hall in Tirol', 'country': 'Austria', 'facility': 'Landeskrankenhaus Hall Gedächtnisambulanz', 'geoPoint': {'lat': 47.28333, 'lon': 11.51667}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'LNK Wagner-Jauregg, Dept. of geriatrics', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Christian Doppler Klinik, Univ. Klinik f. Neurologie', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1080', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'MUW Klin. Pharmakologie und Klinik für Neurologie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'MUW, Klin.Abt.f. Biolog. Psychiatrie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1220', 'city': 'Vienna', 'country': 'Austria', 'facility': 'SMZ-Ost, Psychiatric Dep.', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '51000', 'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'zip': '42000', 'city': 'Varaždin', 'country': 'Croatia', 'facility': 'Opća bolnica Varaždin, Klinika za Neurologiju', 'geoPoint': {'lat': 46.30444, 'lon': 16.33778}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': '"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '10090', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Psihijatrijska Bolnica Vrapče', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '149 50', 'city': 'Prague', 'country': 'Czechia', 'facility': 'University Thomayer Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '150 06', 'city': 'Prague', 'country': 'Czechia', 'facility': 'University Hospital Motol, Clinic of Neurology', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Neurologique Pierre Wertheimer', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '21033', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire (CHU) de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Centre Mémoire de Ressources et de Recherche, Service de Neurologie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital de la Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35064', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de rennes Site Hôtel Dieu', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hopital La Grave', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20251', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '04107', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Arzneimittelforschung Leipzig GmbH, Studienzentrum', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '68159', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '90402', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Studienzentrum PD Dr. Steinwachs', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '90419', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '89073', 'city': 'Ulm/Donau', 'country': 'Germany', 'facility': 'NeuroPoint GmbH'}, {'zip': '040 17', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'EPAMED, s.r.o.', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '071 01', 'city': 'Michalovce', 'country': 'Slovakia', 'facility': 'Psychiatric Hospital Michalovce', 'geoPoint': {'lat': 48.75434, 'lon': 21.9195}}], 'overallOfficials': [{'name': 'Bruno Dubois, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', '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"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiris AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-10-19', 'type': 'RELEASE'}, {'date': '2018-07-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Affiris AG'}}}}