Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006

A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.

This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.

Study Overview

• Status: Terminated
• Conditions: Alzheimer´s Disease
• Intervention / Treatment: Biological: Placebo; Biological: AFFITOPE® AD02

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 2

Contacts and Locations

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.
• 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
• Czech Republic
  • Praha, Czech Republic, 14950
    • University Thomayer Hospital
  • Praha, Czech Republic, 15006
    • University Hospital Motol, Clinic of Neurology
• France
  • Bordeaux Cedex, France, 33076
    • CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard
  • Bron, France, 69500
    • Hopital Neurologique Pierre Wertheimer
  • Dijon, France, 21033
    • Centre Hospitalier Universitaire (CHU) de Dijon
  • Montpellier Cedex, 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
  • Ulm/Donau, Germany, 89073
    • Neuropoint GmbH
• Slovakia
  • Kosice, Slovakia, 04017
    • EPAMED, s.r.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits
• Written informed consent
• Availability of a partner/caregiver
• Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
• Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.

Exclusion Criteria:

• Pregnant women.
• Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
• Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.
• History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
• Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
• Contraindication for MRI imaging
• Presence and/or history of immunodeficiency (e.g., HIV infection).
• Prior and/or current treatment with experimental immunotherapeutics including Intravenous immunoglobulin (IVIG), AD antibody therapy and/or vaccines for AD except AD02.
• Prior and/or current treatment with immunosuppressive drugs.
• Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment.
• Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations	Biological: AFFITOPE® AD02
Active Comparator: Group 2; AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations	Biological: Placebo; Biological: AFFITOPE® AD02

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Measures of Primary Safety and Tolerability Endpoints	Withdrawal criteria; Number of Adverse events (AEs); Number of any serious adverse events (SAE); Alzheimer's Disease Assessment Scale - Cognition (ADAScog); Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL)	19 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Measures of Secondary Efficacy Endpoints	Clinical Dementia Rating Sum of Boxes (CDR-sb); Free and Cued Selective Reminding Test (FCSRT); Standard neuropsychological test battery (CogState); Mini-Mental State Examination (MMSE); Investigator's global evaluation scale (IGE); CDR [global aspects]; Neuropsychiatric Inventory (NPI) [behavior]; quality of life (QOL) -AD	19 months

Collaborators and Investigators

• 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

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Dementia; Alzheimer Disease; Brain Disease; Neurodegenerative Diseases; Mental Disorders; Tauopathies; AFFITOPE® AD02
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: AFF006A; 2012-005280-27 (EudraCT Number)