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

December 10, 2013 updated by: Affiris AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

335

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: AFFITOPE AD02
Biological: active: AFFITOPE AD02
vaccination
Other Names:
  • AFFITOPE AD02
Active Comparator: B: AFFITOPE AD02
Biological: active: AFFITOPE AD02
vaccination
Other Names:
  • AFFITOPE AD02
Active Comparator: C: AFFITOPE AD02
Biological: active: AFFITOPE AD02
vaccination
Other Names:
  • AFFITOPE AD02
Active Comparator: D: Placebo control
Biological: control: Placebo
vaccination
Other Names:
  • placebo
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFF006
  • 2009-016504-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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