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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT01117818
First received: April 19, 2010
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Alzheimer's Disease
Biological: active: AFFITOPE AD02
Biological: control: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • cognitive(ADAS-cog modified) and functional(ADCS-ADL modified) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 335
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
SMZ-Ost, Psychiatric Dep.
Vienna, Austria, 1220
MUW Klin. Pharmakologie und Klinik für Neurologie
Vienna, Austria, 1090
MUW, Klin.Abt.f. Biolog. Psychiatrie
Vienna, Austria, 1090
Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt
Vienna, Austria, 1080
Croatia
Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju
Rijeka, Croatia, 51000
Opća bolnica Varaždin, Klinika za Neurologiju
Varaždin, Croatia, 42000
Psihijatrijska Bolnica Vrapče
Zagreb, Croatia, 10090
Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju
Zagreb, Croatia, 10000
"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju
Zagreb, Croatia, 10000
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
Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie
Nürnberg, Germany, 90419
Studienzentrum PD Dr. Steinwachs
Nürnberg, Germany, 90402
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

No publications provided

Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT01117818     History of Changes
Other Study ID Numbers: AFF006, 2009-016504-22
Study First Received: April 19, 2010
Last Updated: December 10, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014