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Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01117818
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
Affiris AG

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Biological: active: AFFITOPE AD02 Biological: control: Placebo Phase 2

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A: AFFITOPE AD02 Biological: active: AFFITOPE AD02
vaccination
Other Name: AFFITOPE AD02
Active Comparator: B: AFFITOPE AD02 Biological: active: AFFITOPE AD02
vaccination
Other Name: AFFITOPE AD02
Active Comparator: C: AFFITOPE AD02 Biological: active: AFFITOPE AD02
vaccination
Other Name: AFFITOPE AD02
Active Comparator: D: Placebo control Biological: control: Placebo
vaccination
Other Names:
  • placebo
  • control


Outcome Measures
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Primary Outcome Measures :
  1. cognitive(ADAS-cog modified) and functional(ADCS-ADL modified) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI) [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent capability
  • Early AD, based on episodic memory deficit and hippocampal atrophy
  • Age from 50 to 80, inclusive
  • MMSE of 20+
  • Brain magnetic resonance imaging scan consistent with the diagnosis of AD
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver able to attend all visits with patient

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric illness
  • Significant systemic illness
  • Autoimmune disease
  • Prior treatment with experimental immunotherapeutics for AD including IVIG
  • Women of childbearing potential without birth control
  • Contraindication for MRI scan
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117818


Locations
Austria
Landeskrankenhaus Hall Gedächtnisambulanz
Hall in Tirol, Austria, 6060
LNK Wagner-Jauregg, Dept. of geriatrics
Linz, Austria, 4020
Christian Doppler Klinik, Univ. Klinik f. Neurologie
Salzburg, Austria, 5020
Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt
Vienna, Austria, 1080
MUW Klin. Pharmakologie und Klinik für Neurologie
Vienna, Austria, 1090
MUW, Klin.Abt.f. Biolog. Psychiatrie
Vienna, Austria, 1090
SMZ-Ost, Psychiatric Dep.
Vienna, Austria, 1220
Croatia
Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju
Rijeka, Croatia, 51000
Opća bolnica Varaždin, Klinika za Neurologiju
Varaždin, Croatia, 42000
"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju
Zagreb, Croatia, 10000
Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju
Zagreb, Croatia, 10000
Psihijatrijska Bolnica Vrapče
Zagreb, Croatia, 10090
Czech Republic
University Thomayer Hospital
Praha 4, Czech Republic, 149 50
University Hospital Motol, Clinic of Neurology
Praha 5, Czech Republic, 150 06
France
CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard
Bordeaux Cedex, France, 33076
Hôpital Neurologique Pierre Wertheimer
Bron, France, 69500
Centre Hospitalier Universitaire (CHU) de Dijon
Dijon, France, 21033
Centre Mémoire de Ressources et de Recherche, Service de Neurologie
Montpellier Cedex 05, France, 34295
Hôpital de la Pitié-Salpêtrière
Paris, France, 75651
CHU de rennes Site Hôtel Dieu
RENNES Cedex, France, 35064
Hopital La Grave
Toulouse, France, 31059
Germany
Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie
Berlin, Germany, 14050
Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie
Hamburg, Germany, 20251
Arzneimittelforschung Leipzig GmbH, Studienzentrum
Leipzig, Germany, 04107
Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie
Mannheim, Germany, 68159
Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München
Munich, Germany, 81675
Studienzentrum PD Dr. Steinwachs
Nürnberg, Germany, 90402
Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie
Nürnberg, Germany, 90419
NeuroPoint GmbH
Ulm/Donau, Germany, 89073
Slovakia
EPAMED, s.r.o.
Kosice, Slovakia, 040 17
Psychiatric Hospital Michalovce
Michalovce, Slovakia, 071 01
Sponsors and Collaborators
Affiris AG
Investigators
Principal Investigator: 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
More Information
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Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT01117818     History of Changes
Other Study ID Numbers: AFF006
2009-016504-22 ( EudraCT Number )
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders