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

Alzheimer´s Disease Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02008513
• Other study ID #: AFF006A
• Secondary ID: 2012-005280-27
• Status: Terminated
• Phase: Phase 2
• First received: October 30, 2013
• Last updated: June 23, 2015
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: June 2015
• Source: Affiris AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 194
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer´s Disease

Intervention

Biological:
• AFFITOPE® AD02

• Placebo

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Hall Gedächtnisambulanz	Hall in Tirol
Austria	LNK Wagner-Jauregg, Dept. of geriatrics	Linz
Austria	Christian Doppler Klinik, Univ. Klinik f. Neurologie	Salzburg
Austria	MUW Klin. Pharmakologie und Klinik für Neurologie	Vienna
Austria	MUW, Klin.Abt.f. Biolog. Psychiatrie	Vienna
Austria	SMZ-Ost, Psychiatric Dep.	Vienna
Croatia	Klincki Bolnicki Centar Rijeka, Klinika za Psihijatriju	Rijeka
Croatia	Opca bolnica Varaždin, Klinika za Neurologiju	Varaždin
Croatia	"BONIFARM" Poliklinika za klinicku farmakologiju i toksikologiju	Zagreb
Croatia	Psihijatrijska Bolnica Vrapce	Zagreb
Czech Republic	University Hospital Motol, Clinic of Neurology	Praha
Czech Republic	University Thomayer Hospital	Praha
France	CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard	Bordeaux Cedex
France	Hôpital Neurologique Pierre Wertheimer	Bron
France	Centre Hospitalier Universitaire (CHU) de Dijon	Dijon
France	Centre Mémoire de Ressources et de Recherche, Service de Neurologie	Montpellier Cedex
France	Hôpital de la Pitié-Salpêtrière	Paris
France	CHU de Rennes Site Hôtel Dieu	Rennes Cedex
France	Hopital La Grave	Toulouse
Germany	Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie	Berlin
Germany	Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie	Hamburg
Germany	Arzneimittelforschung Leipzig GmbH, Studienzentrum	Leipzig
Germany	Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie	Mannheim
Germany	Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München	Munich
Germany	Studienzentrum PD Dr. Steinwachs	Nürnberg
Germany	NeuroPoint GmbH	Ulm/Donau
Slovakia	EPAMED, s.r.o.	Kosice

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Countries where clinical trial is conducted

Austria,  Croatia,  Czech Republic,  France,  Germany,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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