Trial record 2 of 2 for:    AFFiRiS phase II Alzheimer's

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

This study has been terminated.
(Study AFF006A was early terminated by the sponsor based on the results of study AFF006.)
Sponsor:
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT02008513
First received: October 30, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer´s Disease
Biological: AFFITOPE® AD02
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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-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.

Resource links provided by NLM:


Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Composite Measures of Primary Safety and Tolerability Endpoints [ Time Frame: 19 months ]
    • 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)


Secondary Outcome Measures:
  • Composite Measures of Secondary Efficacy Endpoints [ Time Frame: 19 months ]
    • 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


Enrollment: 194
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: AFFITOPE® AD02 Biological: Placebo

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT02008513

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.Abt.f. Biolog. Psychiatrie
Vienna, Austria, 1090
MUW Klin. Pharmakologie und Klinik für Neurologie
Vienna, Austria, 1090
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
Psihijatrijska Bolnica Vrapče
Zagreb, Croatia, 10090
Czech Republic
University Thomayer Hospital
Praha, Czech Republic, 14950
University Hospital Motol, Clinic of Neurology
Praha, Czech Republic, 15006
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, 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
NeuroPoint GmbH
Ulm/Donau, Germany, 89073
Slovakia
EPAMED, s.r.o.
Kosice, Slovakia, 04017
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: NCT02008513     History of Changes
Other Study ID Numbers: AFF006A, 2012-005280-27
Study First Received: October 30, 2013
Last Updated: June 23, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Affiris AG:
AFFITOPE® AD02
Alzheimer Disease
Dementia
Brain Disease
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders

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

ClinicalTrials.gov processed this record on October 22, 2014